Surgery-ComplicationsTHRIVENCT05991453
Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
A study testing Anesthetic technique Propofol TIVA and Anesthetic technique inhaled agent in people with Surgery-Complications and Anesthesia Complication, run by Washington University School of Medicine at 24 sites in United States.
Trial summary
The investigators will conduct a 13,000-patient randomized multi-center trial to determine (i) which general anesthesia technique yields superior patient recovery experiences in any of three surgical categories ((a) major inpatient surgery, (b) minor inpatient surgery, (c) outpatient surgery) and (ii) whether TIVA… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery-Complications, Anesthesia Complication, Anesthesia Awareness
- What is being tested?
- Anesthetic technique Propofol TIVA and Anesthetic technique inhaled agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,000 participants
- Where
- 24 sitesUnited States
- Study dates
- 13 Sep 2023to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each patient must meet all of the following criteria:
- Aged 18 years or older
- Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia with a tracheal tube or laryngeal mask airway (or similar supra-glottic device)
Who cannot join
- Patients will not be enrolled if any of the following criteria are met:
- Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option)
- Pregnancy (based on patient report or positive test on the day of surgery)
- Surgical procedure requiring general, regional, neuraxial anesthesia administered by an anesthesia clinician (anesthesiologist, CRNA, anesthesiology assistant) occurring within 30 days prior to or planned to occur within 30 days after surgery date
- Contraindication to propofol TIVA or INVA (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia) based on self-report
- Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring).
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- Locally approved, written protocol mandating a particular anesthetic technique
- History of possible or definite intraoperative awareness during general anesthesia based on patient self-report
- Planned postoperative intubation
- Current incarceration
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
United States24 sites, 24 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Allison Janda, MD, ajanda@med.umich.edu
Rachel Shoemake, rahersho@med.umich.edu
- Recruiting
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
Joseph Walpole, MD, PhD, jwalpol1@jhmi.edu
Colleen Mennie, 410-550-0100, Cmennie1@jh.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Amit Bardia, MD, abardia@mgb.org
Ariel Mueller, MA, almueller@mgh.harvard.edu
- Recruiting
Brigham & Women's
Boston, Massachusetts, 02115
Luigino Nascimben, MD, lnascimben@bwh.harvard.edu
Angela Yang, ayang41@bwh.harvard.edu
- Recruiting
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599
Jay Schoenherr, MD, jay_schoenherr@med.unc.edu
Michelle Becton, 919-966-5136, michelle_becton@med.unc.edu
- Recruiting
UVA Health
Charlottesville, Virginia, 22908
Bhiken Naik, MD, bin4n@uvahealth.org
Avani Jain, XNJ5VZ@uvahealth.org
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
Kunal Karamchandani, MD, Kunal.Karamchandani@utsouthwestern.edu
Farzin Ahmed, 214-648-3111, Farzin.Ahmed@UTSouthwestern.edu
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Anoop Chhina, MD, achhina1@hfhs.org
Katherine Nowak, PhD, KNowak2@hfhs.org
- Recruiting
Duke University
Durham, North Carolina, 27708
Michael Manning, MD, michael.manning@duke.edu
Kelly Rodden, BSN, kelly.rodden@duke.edu
- Recruiting
University of Texas - MD Anderson
Houston, Texas, 77030
Juan Cata, MD, jcata@mdanderson.org
Mohamed Hussein, MHussein1@mdanderson.org
- Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Stacie Deiner, MD, Stacie.G.Deiner@Hitchcock.org
Emma Toes, Emma.K.Toes@hitchcock.org
- Recruiting
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, 72205
Geoffrey Muller, MD, gdmuller@uams.edu
Gwendolyn Cobbs, gfcobbs@uams.edu
- Recruiting
Yale School of Medicine
New Haven, Connecticut, 06510
Jaime B Hyman, MD, jaime.hyman@yale.edu
Emmy St. John, emelina.stjohn@yale.edu
- Recruiting
NYU Langone
New York, New York, 10012
Simon Tom, MD, Simon.Tom@nyulangone.org
Lola Franco, Lola.Franco@nyulangone.org
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Kane O Pryor, MD, kap9009@med.cornell.edu
Michele L Steinkamp, mls9004@med.cornell.edu
- Not yet recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Caoimhe Duffy, MD, Caoimhe.Duffy@pennmedicine.upenn.edu
Karah Whatley, Karah.Whatley@pennmedicine.upenn.edu
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19140
Sean Baskin, DO, Sean.Baskin@tuhs.temple.edu
Alexis Bailey, 800-836-7536, alexis.bailey1@temple.edu
- Recruiting
Oregon Health and Sciences University
Portland, Oregon, 97239
Michael Aziz, MD, azizm@ohsu.edu
Sarah Feller, fellersa@ohsu.edu
- Recruiting
University of Utah - Medical
Salt Lake City, Utah, 84132
Rachel Danowit, MD, Rachel.Danowit@hsc.utah.edu
Madison Bunnell, madison.bunnell@utah.edu
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Lee-lynn Chen, MD, lee-lynn.chen@ucsf.edu
Ariel Asino, Arielle.Asino@ucsf.edu
- Recruiting
University of Washington
Seattle, Washington, 98195
Karen Domino, MD, kdomino@uw.edu
Sasha Luce, aluce1@uw.edu
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Laura Swisher, goodl@wustl.edu
Sherry McKinnon, MS, smckinnon@wustl.edu
- Not yet recruiting
Stanford University
Stanford, California, 94305
David Drover, MD, ddrover@stanford.edu
Ariel Kay Callman, arielkay@stanford.edu
- Recruiting
Wake Forest
Winston-Salem, North Carolina, 27109
Ashish Khanna, MD, akhanna@wakehealth.edu
Jessica Reeves, Jessica.A.Reeves@Advocatehealth.org
About this study
The investigators will conduct a 13,000-patient randomized multi-center trial to determine (i) which general anesthesia technique yields superior patient recovery experiences in any of three surgical categories ((a) major inpatient surgery, (b) minor inpatient surgery, (c) outpatient surgery) and (ii) whether TIVA confers no more than a small (0.2 %) increased risk of intraoperative awareness than INVA in patients undergoing both outpatient and inpatient surgeries
- Conditions
- Surgery-Complications, Anesthesia Complication, Anesthesia Awareness, Anesthesia, Surgery, Quality of Life
- Being tested
- Anesthetic technique Propofol TIVA, Anesthetic technique inhaled agent
- Medical subject headings
- Intraoperative Awareness, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthetic technique Propofol TIVAOther
Also called Propofol TIVA
Propofol TIVA no inhaled agent
Anesthetic technique inhaled agentOther
Also called Inhaled agent
Must administer inhaled agent.
| Study group | Role | What they receive |
|---|---|---|
| Propofol total intravenous anesthesia (TIVA) | Active comparator | No administration of inhaled agent. Receives: Other: Anesthetic technique Propofol TIVA |
| inhaled volatile general anesthesia (INVA) | Active comparator | Must administer inhaled agent. Receives: Other: Anesthetic technique inhaled agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Measured: Postoperative day 1
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after minor inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Measured: Postoperative day 1
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after outpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Measured: Postoperative day 1
Incidence of definite intraoperative awareness with recall
The modified Brice questionnaire is used to screen for intraoperative awareness. A positive screen (a patient who reports remembering anything between going to sleep for their surgical procedure and waking up after) on the modified Brice questionnaire is followed by a structured interview. A panel of expert adjudicators determines whether or not this was definite intraoperative awareness.
Measured: Postoperative day 30
Secondary outcomes (56)
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after major inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Measured: postoperative day 0
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after minor inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Measured: postoperative day 0
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after outpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Measured: postoperative day 0
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after major inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Measured: postoperative day 2
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after minor inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Measured: postoperative day 2
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after outpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Measured: postoperative day 2
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after major inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Measured: postoperative day 7
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after minor inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Measured: postoperative day 7
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after outpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Measured: postoperative day 7
Days Alive and at Home at 30 days after major inpatient surgery
Patient hospital length of stay after the surgery is documented. A patient completed survey assesses hospital re-admission since discharge from surgery and days spent in the hospital since original discharge.
Measured: postoperative day 30
Days Alive and at Home at 30 days after minor inpatient surgery
Patient hospital length of stay after the surgery is documented. A patient completed survey assesses hospital re-admission since discharge from surgery and days spent in the hospital since original discharge.
Measured: postoperative day 30
Days Alive and at Home at 30 days after outpatient surgery
Patient hospital length of stay after the surgery is documented. A patient completed survey assesses hospital re-admission since discharge from surgery and days spent in the hospital since original discharge.
Measured: postoperative day 30
Incidence of delirium on postoperative day 0 after major inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.
Measured: postoperative day 0
Incidence of delirium on postoperative day 0 after minor inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.
Measured: postoperative day 0
Incidence of delirium on postoperative day 0 after outpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.
Measured: postoperative day 0
Incidence of delirium on postoperative day 1 after major inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.
Measured: postoperative day 1
Incidence of delirium on postoperative day 1 after minor inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.
Measured: postoperative day 1
Delirium Severity Score on postoperative day 0 after major inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.
Measured: postoperative day 0
Delirium Severity Score on postoperative day 0 after minor inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.
Measured: postoperative day 0
Delirium Severity Score on postoperative day 0 after outpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.
Measured: postoperative day 0
Delirium Severity Score on postoperative day 1 after major inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.
Measured: postoperative day 1
Delirium Severity Score on postoperative day 1 after minor inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.
Measured: postoperative day 1
Incidence of Subsyndromal delirium on postoperative day 0 after major inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.
Measured: postoperative day 0
Incidence of Subsyndromal delirium on postoperative day 0 after minor inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.
Measured: postoperative day 0
Incidence of Subsyndromal delirium on postoperative day 0 after outpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.
Measured: postoperative day 0
Incidence of Subsyndromal delirium on postoperative day 1 after major inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.
Measured: postoperative day 1
Incidence of Subsyndromal delirium on postoperative day 1 after minor inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.
Measured: postoperative day 1
Health-related quality-of-life on postoperative day 30 after major inpatient surgery
EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Measured: postoperative day 30
Health-related quality-of-life on postoperative day 30 after minor inpatient surgery
EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Measured: postoperative day 30
Health-related quality-of-life on postoperative day 30 after outpatient surgery
EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Measured: postoperative day 30
Health-related quality-of-life on postoperative day 90 after major inpatient surgery
EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Measured: postoperative day 90
Health-related quality-of-life on postoperative day 90 after minor inpatient surgery
EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Measured: postoperative 90 days
Health-related quality-of-life on postoperative day 90 after outpatient surgery
EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Measured: postoperative day 90
Health-related quality-of-life on postoperative day 180 after major inpatient surgery
EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Measured: postoperative day 180
Health-related quality-of-life on postoperative day 180 after minor inpatient surgery
EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Measured: postoperative day 180
Health-related quality-of-life on postoperative day 180 after outpatient surgery
EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Measured: postoperative day 180
Health-related quality-of-life on postoperative day 365 after major inpatient surgery
EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Measured: postoperative day 365
Health-related quality-of-life on postoperative day 365 after minor inpatient surgery
EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Measured: postoperative day 365
Health-related quality-of-life on postoperative day 365 after outpatient surgery
EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Measured: postoperative day 365
Functional status on postoperative day 30 after major inpatient surgery.
The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.
Measured: postoperative day 30
Functional status on postoperative day 30, after minor inpatient surgery.
The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.
Measured: postoperative day 30
Functional status on postoperative day 30, after outpatient surgery.
The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.
Measured: postoperative day 30
Functional status on postoperative day 90 after major inpatient surgery.
The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.
Measured: postoperative day 90
Functional status on postoperative day 90 after minor inpatient surgery.
The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.
Measured: postoperative day 90
Functional status on postoperative day 90 after outpatient surgery.
The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.
Measured: postoperative day 90
Patient satisfaction with anesthesia on postoperative day 2
The Bauer questionnaire is a patient self-reported survey assessing anesthesia-related discomfort and satisfaction with anesthesia care.
Measured: postoperative day 2
Respiratory Failure on postoperative day 0
Respiratory failure defined as unplanned postoperative intubation or reintubation or continued mechanical ventilation > 6 hours postoperatively. Reintubation due to reoperation is excluded.
Measured: postoperative day 0
Kidney Injury on postoperative day 7
Kidney Injury defined as a serum creatinine increase of 50% or 0.3 mg/dl from preoperative baseline
Measured: postoperative day 7
All-Cause Mortality at POD30
All-Cause Mortality at POD30
Measured: postoperative day 30
All-Cause Mortality at POD90
All-Cause Mortality at POD90
Measured: postoperative day 90
Intraoperative Hypotension (1)
Intraoperative Hypotension defined as cumulative duration of mean arterial pressure <55 mmHg for 20 minutes or greater.
Measured: postoperative day 0
Intraoperative Hypotension (2)
Intraoperative hypotension defined as cumulative duration of mean arterial pressure < 65 mmHg for 20 minutes or greater.
Measured: postoperative day 0
Moderate or Severe Intraoperative Patient Movement
Moderate or Severe Intraoperative Patient Movement is based on clinician report.
Measured: postoperative day 0
Unplanned Admission After Outpatient Surgery in an Ambulatory Setting
Hospital admission no later than 24 hours postoperatively after outpatient surgery in a free-standing ambulatory surgery center setting
Measured: postoperative days 0 and 1
Incidence of propofol-related infusion syndrome
Propofol related infusion syndrome, defined as acute refractory bradycardia in the presence of metabolic acidosis, and at least one of the following: rhabdomyolysis, acute kidney injury or hypertriglyceridemia, occurring after the start of propofol intraoperatively and within 6 hours postoperatively.
Measured: postoperative day 0
Incidence of malignant hyperthermia
Malignant hyperthermia, defined as unexplained muscle rigidity, tachycardia, hypercapnia, and rapidly increasing temperature leading to metabolic acidosis, rhabdomyolysis, disseminated intravascular coagulation, and ventricular arrhythmias, occurring after the start of an inhaled volatile agent intraoperatively and within 6 hours postoperatively.
Measured: postoperative day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start13 Sep 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgery-ComplicationsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Michigan
- Responsible party
- Principal investigator, Michael Avidan, Washington University School of Medicine
- Investigators
- Sachin Kheterpal, MD, Principal investigator, University of MichiganMichael S Avidan, MBBCh, Principal investigator, Washington University School of MedicineAllison Janda, MD, Study director, University of MichiganMark Neuman, MD, Study director, University of PennsylvaniaBethany Pennington, PharmD, Study director, Washington University School of MedicineDouglas Colquhoun, MBChB, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991453
- Sponsor's protocol ID
- 202304082
- Acronym
- THRIVE
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per the contract with the funder PCORI, the THRIVE Data Sharing Plan will be consistent with PCORI's Policy for Data Management and Data Sharing, which calls for the researchers PCORI funds to share their data sets and documentation for reanalysis and reuse. THRIVE will upload a deidentified dataset to the Patient-Centered Outcomes Data Repository (PCODR), which was created and is hosted by the Inter-University Consortium for Political and Social Research (ICPSR), a unit within the Institute for Social Research at the University of Michigan. The THRIVE study, as the Awardee, will enter into a Data Contributor Agreement (DCA) with ICPSR. The DCA governs the data deposition and establishes the Awardee's rights and obligations. The data package will be transferred to the data repository by October 1, 2028, per the contract with PCORI.
Publications
Tellor Pennington BR, Janda AM, Colquhoun DA, Neuman MD, Kidwell KM, Spino C, Thelen-Perry S, Krambrink A, Huang S, Ignacio R, Wu Z, Swisher L, Cloyd C, Vaughn MT, Pescatore NA, Bollini ML, Mashour GA, Hassett A, Kent CD, Vlisides PE, Avidan MS, Kheterpal S; ˠTHRIVE Research Group. Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anaesthesia (THRIVE) randomised controlled trial in the USA: A protocol. BMJ Open. 2025 Sep 14;15(9):e103836. doi: 10.1136/bmjopen-2025-103836.
PubMed 40953862
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
- ClinicalTrials.gov ID
- NCT05991453
- Acronym / sponsor ID
- THRIVE / 202304082
- Conditions
- Surgery-Complications, Anesthesia Complication, Anesthesia Awareness, Anesthesia, Surgery, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13,000 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Michigan
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct a 13,000-patient randomized multi-center trial to determine (i) which general anesthesia technique yields superior patient recovery experiences in any of three surgical categories ((a) major inpatient surgery, (b) minor inpatient surgery, (c) outpatient surgery) and (ii) whether TIVA confers no more than a small (0.2 %) increased risk of intraoperative awareness than INVA in patients undergoing both outpatient and inpatient surgeries
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol total intravenous anesthesia (TIVA) | Active comparator | Other: Anesthetic technique Propofol TIVANo administration of inhaled agent. |
| inhaled volatile general anesthesia (INVA) | Active comparator | Other: Anesthetic technique inhaled agentMust administer inhaled agent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia with a tracheal tube or laryngeal mask airway (or similar supra-glottic device)
Key exclusion criteria (10 listed)
- Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option)
- Pregnancy (based on patient report or positive test on the day of surgery)
- Surgical procedure requiring general, regional, neuraxial anesthesia administered by an anesthesia clinician (anesthesiologist, CRNA, anesthesiology assistant) occurring within 30 days prior to or planned to occur within 30 days after surgery date
- Contraindication to propofol TIVA or INVA (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia) based on self-report
- Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthetic technique Propofol TIVAAlso: Propofol TIVAPropofol TIVA no inhaled agent | Other | Propofol total intravenous anesthesia (TIVA) |
| Anesthetic technique inhaled agentAlso: Inhaled agentMust administer inhaled agent. | Other | inhaled volatile general anesthesia (INVA) |
Primary outcome
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery
Time frame: Postoperative day 1
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after minor inpatient surgery
Time frame: Postoperative day 1
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after outpatient surgery
Time frame: Postoperative day 1
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Incidence of definite intraoperative awareness with recall
Time frame: Postoperative day 30
The modified Brice questionnaire is used to screen for intraoperative awareness. A positive screen (a patient who reports remembering anything between going to sleep for their surgical procedure and waking up after) on the modified Brice questionnaire is followed by a structured interview. A panel of expert adjudicators determines whether or not this was definite intraoperative awareness.
56 secondary outcomes
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after major inpatient surgery
Time frame: postoperative day 0
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after minor inpatient surgery
Time frame: postoperative day 0
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after outpatient surgery
Time frame: postoperative day 0
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after major inpatient surgery
Time frame: postoperative day 2
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after minor inpatient surgery
Time frame: postoperative day 2
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after outpatient surgery
Time frame: postoperative day 2
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after major inpatient surgery
Time frame: postoperative day 7
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after minor inpatient surgery
Time frame: postoperative day 7
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after outpatient surgery
Time frame: postoperative day 7
Days Alive and at Home at 30 days after major inpatient surgery
Time frame: postoperative day 30
Days Alive and at Home at 30 days after minor inpatient surgery
Time frame: postoperative day 30
Days Alive and at Home at 30 days after outpatient surgery
Time frame: postoperative day 30
Incidence of delirium on postoperative day 0 after major inpatient surgery
Time frame: postoperative day 0
Incidence of delirium on postoperative day 0 after minor inpatient surgery
Time frame: postoperative day 0
Incidence of delirium on postoperative day 0 after outpatient surgery
Time frame: postoperative day 0
Incidence of delirium on postoperative day 1 after major inpatient surgery
Time frame: postoperative day 1
Incidence of delirium on postoperative day 1 after minor inpatient surgery
Time frame: postoperative day 1
Delirium Severity Score on postoperative day 0 after major inpatient surgery
Time frame: postoperative day 0
Delirium Severity Score on postoperative day 0 after minor inpatient surgery
Time frame: postoperative day 0
Delirium Severity Score on postoperative day 0 after outpatient surgery
Time frame: postoperative day 0
Delirium Severity Score on postoperative day 1 after major inpatient surgery
Time frame: postoperative day 1
Delirium Severity Score on postoperative day 1 after minor inpatient surgery
Time frame: postoperative day 1
Incidence of Subsyndromal delirium on postoperative day 0 after major inpatient surgery
Time frame: postoperative day 0
Incidence of Subsyndromal delirium on postoperative day 0 after minor inpatient surgery
Time frame: postoperative day 0
Incidence of Subsyndromal delirium on postoperative day 0 after outpatient surgery
Time frame: postoperative day 0
Incidence of Subsyndromal delirium on postoperative day 1 after major inpatient surgery
Time frame: postoperative day 1
Incidence of Subsyndromal delirium on postoperative day 1 after minor inpatient surgery
Time frame: postoperative day 1
Health-related quality-of-life on postoperative day 30 after major inpatient surgery
Time frame: postoperative day 30
Health-related quality-of-life on postoperative day 30 after minor inpatient surgery
Time frame: postoperative day 30
Health-related quality-of-life on postoperative day 30 after outpatient surgery
Time frame: postoperative day 30
Health-related quality-of-life on postoperative day 90 after major inpatient surgery
Time frame: postoperative day 90
Health-related quality-of-life on postoperative day 90 after minor inpatient surgery
Time frame: postoperative 90 days
Health-related quality-of-life on postoperative day 90 after outpatient surgery
Time frame: postoperative day 90
Health-related quality-of-life on postoperative day 180 after major inpatient surgery
Time frame: postoperative day 180
Health-related quality-of-life on postoperative day 180 after minor inpatient surgery
Time frame: postoperative day 180
Health-related quality-of-life on postoperative day 180 after outpatient surgery
Time frame: postoperative day 180
Health-related quality-of-life on postoperative day 365 after major inpatient surgery
Time frame: postoperative day 365
Health-related quality-of-life on postoperative day 365 after minor inpatient surgery
Time frame: postoperative day 365
Health-related quality-of-life on postoperative day 365 after outpatient surgery
Time frame: postoperative day 365
Functional status on postoperative day 30 after major inpatient surgery.
Time frame: postoperative day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Derived from this study: PubMed 40953862Tellor Pennington BR, Janda AM, Colquhoun DA, Neuman MD, Kidwell KM, Spino C, Thelen-Perry S, Krambrink A, Huang S, Ignacio R, Wu Z, Swisher L, Cloyd C, Vaughn MT, Pescatore NA, Bollini ML, Mashour GA, Hassett A, Kent CD, Vlisides PE, Avidan MS, Kheterpal S; ˠTHRIVE Research Group. Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anaesthesia (THRIVE) randomised controlled trial in the USA: A protocol. BMJ Open. 2025 Sep 14;15(9):e103836. doi: 10.1136/bmjopen-2025-103836.
- Individual participant dataSharing planned: Yes. Per the contract with the funder PCORI, the THRIVE Data Sharing Plan will be consistent with PCORI's Policy for Data Management and Data Sharing, which calls for the researchers PCORI funds to share their data sets and documentation for reanalysis and reuse. THRIVE will upload a deidentified dataset to the Patient-Centered Outcomes Data Repository (PCODR), which was created and is hosted by the Inter-University Consortium for Political and Social Research (ICPSR), a unit within the Institute for Social Research at the University of Michigan. The THRIVE study, as the Awardee, will enter into a Data Contributor Agreement (DCA) with ICPSR. The DCA governs the data deposition and establishes the Awardee's rights and obligations. The data package will be transferred to the data repository by October 1, 2028, per the contract with PCORI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sachin Kheterpal, MD principal investigator
University of Michigan
Michael S Avidan, MBBCh principal investigator
Washington University School of Medicine
Allison Janda, MD study director
University of Michigan
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthetic technique Propofol TIVA and Anesthetic technique inhaled agent in people with Surgery-Complications and Anesthesia Complication, run by Washington University School of Medicine at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Swisher (314-286-1024, goodl@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery (time frame: Postoperative day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05991453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.