Surgery--ComplicationsPhase 3THRIVENCT05346588
THRIVE Feasibility Trial
A Phase 3 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 4 sites in United States.
Trial summary
To evaluate the feasibility of a pragmatic, large scale, comparative effectiveness, randomized evaluation of patient experience of intravenous propofol versus inhaled volatile anesthesia. 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
- 300 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Sep 2022to 28 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 18 years or older
- Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia, including a tracheal tube or laryngeal mask airway (or similar supra-glottic device)
Who cannot join
- Inability to provide informed consent in English
- 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 inhaled volatile (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia)
- Surgical procedures requiring specific general anesthesia option (for example, TIVA required for neuromonitoring).
- Hospital approved, written protocol mandating a particular technique
- History of intraoperative awareness during general anesthesia based on patient self-report on the day of consent
- Planned postoperative intubation
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48109
Hosptial of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305
About this study
Official title: Feasibility Study for the Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia (THRIVE) Trial
To evaluate the feasibility of a pragmatic, large scale, comparative effectiveness, randomized evaluation of patient experience of intravenous propofol versus inhaled volatile anesthesia.
Read the detailed description
Two-center single-blinded randomized feasibility study, with randomization 1:1 to either propofol TIVA or inhaled volatile general anesthesia for patients who are receiving elective non-cardiac surgery. Patients will be stratified by clinical site with 150 participants per site.
- Conditions
- Surgery--Complications, Anesthesia Complication, Anesthesia Awareness, Anesthesia Emergence Delirium, Anesthesia, Surgery
- Being tested
- Anesthetic technique Propofol TIVA, Anesthetic technique inhaled agent
- Keywords
- Quality of recovery, Intraoperative awareness
- Medical subject headings
- Intraoperative Awareness, Emergence Delirium, Pain, Postoperative, Postoperative Nausea and Vomiting, Depression, Sleep Disorders, Circadian Rhythm
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 | 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.
Proportion participating
Proportion of patients who are approached to participate by the study team and who consent to participate in the study.
Measured: 8 months
Proportion receiving TIVA
Proportion of patients in the propofol TIVA group who receive per protocol treatment (i.e. they receive no inhaled agents as part of their anesthetic).
Measured: 8 months
Proportion receiving inhaled anesthesia
Proportion of patients in the inhaled volatile group who receive per protocol treatment (i.e. they do receive inhaled agents as part of their anesthetic).
Measured: 8 months
Secondary outcomes (1)
Completeness of data collection
Completeness of data collection (defined as the percentage of instruments or data fields completed with at least 90% of expected forms or relevant fields completed at each time point and with each instrument)
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start29 Sep 2022
- Primary completion16 Apr 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, University of Pennsylvania, Stanford University, Patient-Centered Outcomes Research Institute
- 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 Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346588
- Sponsor's protocol ID
- 202205053
- Acronym
- THRIVE
- Status last verified
- Nov 2023
- First submitted
- 11 Mar 2022
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Janda AM, Tellor Pennington BR, Colquhoun DA, Kumar SS, Neuman MD, Politi MC, Spino C, Kidwell KM, Swisher L, Bollini M, Vaughn MT, Cloyd C, Pescatore NA, Thelen-Perry S, Gregory SH, du Toit L, Henrichs B, Torres B, Avidan MS, Kheterpal S; THRIVE research group. Feasibility Pilot Trial for the Trajectories of Recovery after Intravenous Propofol versus Inhaled Volatile Anesthesia (THRIVE) Pragmatic Randomized Clinical Trial. Anesthesiology. 2026 Jul 1;145(1):59-71. doi: 10.1097/ALN.0000000000006089. Epub 2026 Apr 8.
PubMed 41950401Tellor Pennington BR, Colquhoun DA, Neuman MD, Politi MC, Janda AM, Spino C, Thelen-Perry S, Wu Z, Kumar SS, Gregory SH, Avidan MS, Kheterpal S; THRIVE research group. Feasibility pilot trial for the Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anesthesia (THRIVE) pragmatic randomised controlled trial. BMJ Open. 2023 Apr 17;13(4):e070096. doi: 10.1136/bmjopen-2022-070096.
PubMed 37068889
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for the Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia (THRIVE) Trial
- ClinicalTrials.gov ID
- NCT05346588
- Acronym / sponsor ID
- THRIVE / 202205053
- Conditions
- Surgery--Complications, Anesthesia Complication, Anesthesia Awareness, Anesthesia Emergence Delirium, Anesthesia, Surgery
- Keywords
- Quality of recovery, Intraoperative awareness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Michigan, University of Pennsylvania, Stanford University, Patient-Centered Outcomes Research Institute
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 16 Apr 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 26 Apr 2022 (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.
To evaluate the feasibility of a pragmatic, large scale, comparative effectiveness, randomized evaluation of patient experience of intravenous propofol versus inhaled volatile anesthesia.
Detailed description
Two-center single-blinded randomized feasibility study, with randomization 1:1 to either propofol TIVA or inhaled volatile general anesthesia for patients who are receiving elective non-cardiac surgery. Patients will be stratified by clinical site with 150 participants per site.
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 | 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 (2 listed)
- 18 years or older
- Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia, including a tracheal tube or laryngeal mask airway (or similar supra-glottic device)
Key exclusion criteria (8 listed)
- Inability to provide informed consent in English
- 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 inhaled volatile (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia)
- Surgical procedures requiring specific general anesthesia option (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 |
Primary outcome
Proportion participating
Time frame: 8 months
Proportion of patients who are approached to participate by the study team and who consent to participate in the study.
Proportion receiving TIVA
Time frame: 8 months
Proportion of patients in the propofol TIVA group who receive per protocol treatment (i.e. they receive no inhaled agents as part of their anesthetic).
Proportion receiving inhaled anesthesia
Time frame: 8 months
Proportion of patients in the inhaled volatile group who receive per protocol treatment (i.e. they do receive inhaled agents as part of their anesthetic).
1 secondary outcome
Completeness of data collection
Time frame: 11 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Derived from this study: PubMed 41950401Janda AM, Tellor Pennington BR, Colquhoun DA, Kumar SS, Neuman MD, Politi MC, Spino C, Kidwell KM, Swisher L, Bollini M, Vaughn MT, Cloyd C, Pescatore NA, Thelen-Perry S, Gregory SH, du Toit L, Henrichs B, Torres B, Avidan MS, Kheterpal S; THRIVE research group. Feasibility Pilot Trial for the Trajectories of Recovery after Intravenous Propofol versus Inhaled Volatile Anesthesia (THRIVE) Pragmatic Randomized Clinical Trial. Anesthesiology. 2026 Jul 1;145(1):59-71. doi: 10.1097/ALN.0000000000006089. Epub 2026 Apr 8.
- Derived from this study: PubMed 37068889Tellor Pennington BR, Colquhoun DA, Neuman MD, Politi MC, Janda AM, Spino C, Thelen-Perry S, Wu Z, Kumar SS, Gregory SH, Avidan MS, Kheterpal S; THRIVE research group. Feasibility pilot trial for the Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anesthesia (THRIVE) pragmatic randomised controlled trial. BMJ Open. 2023 Apr 17;13(4):e070096. doi: 10.1136/bmjopen-2022-070096.
- Individual participant dataSharing planned: No
Related trials for Surgery--Complications
Not yet recruiting
The Effect of Compound Chamomile and Lidocaine Hydronchloride Gel as an Endotracheal Tube Lubricant on Postoperative Pharyngeal and Laryngeal Complications in Thoracic Surgery Patients
Postoperative Sore Throat
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Active, not recruitingPhase 3
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v7
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
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. This study is not recruiting at the moment.
Sachin Kheterpal, MD principal investigator
University of Michigan
Michael S Avidan, MBBcH principal investigator
Washington Univeristy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 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 4 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion participating (time frame: 8 months). The study lists 3 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 NCT05346588, which also lists 2 linked publications.
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 24 Nov 2023.