SurgeryPhase 4NCT03939923
Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery
A Phase 4 study testing Rocuronium, Neostigmine and Glycopyrrolate in people with Surgery and Coronary Artery Disease, run by West Virginia University at 1 site in United States.
Trial summary
The purpose of this study is to examine whether the use of Sugammadex will reduce time from reversal to extubation and improve other post extubation outcomes in Coronary artery bypass grafting patients. This study is a prospective, clinical interventional, randomized single blinded single-center design. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Surgery, Coronary Artery Disease
- What is being tested?
- Rocuronium, Neostigmine and Glycopyrrolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 30 Jul 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 70 years
- American Society of Anesthesiology physical status I-4
- Isolated coronary artery bypass graft surgery (CABG)
- Ability to give written informed consent
Who cannot join
- Any other surgical procedure concomitant to CABG surgery
- Known or suspected neuromuscular disease/pre-existing weakness
- Creatinine clearance less than 30 ml/min
- Bradycardia of less than 40 beats/min
- Pregnancy, breastfeeding women
- Known or suspected allergy to BRIDION® (sugammadex),neostigmine, or rocuronium
Show all 16Show fewer
- Patients with contraindications towards sugammadex, neostigmine, or rocuronium
- Patients included in another trial within the last 30 days
- Patients with legal guardians or surrogate decision-making
- Female Patients who refuse to use non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days if receiving sugammadex.
- Patients undergoing emergency surgery
- Patient refusal
- Patients with ejection fraction <30%
- Patients with restrictive and obstructive lung disease
- Patients with obstructive sleep apnea
- Patients with Body Mass Index greater than 40
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine whether the use of Sugammadex will reduce time from reversal to extubation and improve other post extubation outcomes in Coronary artery bypass grafting patients. This study is a prospective, clinical interventional, randomized single blinded single-center design. The nurses in the cardiac intensive care unit will be blinded to treatment allocation (Group 1 or 2).
Read the detailed description
Enhanced recovery pathways and early extubation of subjects undergoing cardiac procedures has now become mainstay, especially with the advent of minimally invasive procedures .
To facilitate optimal recovery after extubation; muscle strength is vital to prevent reintubation, improved deglutition and quicker transition to lower oxygen requirements, and better respiratory and cardiac hemodynamics. It also expedites de-escalation of acuity of care. Several studies have shown residual muscle weakness after full reversal with neostigmine and glycopyrrolate. Sugammadex is a direct reversal agent and can provide superior muscle strength, which optimizes respiratory function thereby preventing atelectasis, hypoxia and potentially avoiding reintubation.
- Conditions
- Surgery, Coronary Artery Disease
- Being tested
- Rocuronium, Neostigmine, Glycopyrrolate, Sugammadex
- Keywords
- Coronary Artery Bypass Grafting Surgery, Sugammadex
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Intubation with Rocuronium 1.0-1.2 mg/kg (vitals maintained within 20% of baseline. Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure.
NeostigmineDrug
Reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage)
GlycopyrrolateDrug
Reversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage)
SugammadexDrug
Reversal with Sugammadex (2mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| Neostigmine/Glycopyrrolate | Active comparator | Group 1: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on train of four (TOF) watch monitor reading recorded every 15 minutes. Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage). Receives: Drug: Rocuronium; Drug: Neostigmine; Drug: Glycopyrrolate |
| Sugammadex | Active comparator | Group 2: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on train of four (TOF) watch monitor reading recorded every 15 minutes. Group 2 (treatment) will receive reversal with Sugammadex (2mg/kg). Receives: Drug: Rocuronium; Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Extubation
Time to extubation: West Virginia University Hospitals use an electronic medical record (EMR) to chart "procedure stop." The definition for "time to extubation" is from the time the investigators chart "procedure stop" to the time of "extubation".
Measured: 0 minutes of study drug to 3 days after study drug administration
Secondary outcomes (5)
Heart Rate
Heart rate post-reversal prior to extubation
Measured: 0 minutes to 2 hours after study drug administration
Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal)
Blood pressure; measure of systolic blood pressure of subject is obtained post-reversal prior to extubation of trachea
Measured: 0 minutes to 2 hours after study drug administration
Tidal Volume
Tidal volume post-reversal prior to extubation
Measured: between 30 minutes to 1 hour after extubation
Peak Flow Rate
Peak flow rate - measured by peak flow meter post-extubation at 30-60 mins
Measured: 30-60 minutes post-extubation
Swallowing Capacity
In the intensive care unit: If the patient awake and alert, is able to be positioned, can cough when asked, able to follow command to lick top and bottom lip, and is able to breathe freely then a registered nurse bedside swallowing/dysphagia screen is performed at a time point somewhere between 30 and 60 minutes following the operating room extubation. To perform the screen, a teaspoon is used to place distilled water on each subject's tongue, 3 mL each time 2 consecutive times. Then 3 ounces of water intake. The patient is asked to swallow the water to evaluate the swallowing ability. Aspiration of fluid (choking) subjectively divided into 4 categories: normal, no choking or hoarse voice after swallowing; mild, no choking but slight hoarseness of voice; moderate, no choking but a clearly identifiable hoarseness of voice; severe, choking.
Measured: Between 30 and 60 minutes post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 May 2019
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015 mg/kg up to 1mg maximal dosage). Group 2 (treatment) will receive reversal with sugammadex 2 mg/kg.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Ellison, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939923
- Sponsor's protocol ID
- 1806161309
- Status last verified
- Dec 2023
- First submitted
- 2 Feb 2019
- Last updated
- 27 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Badhwar V, Esper S, Brooks M, Mulukutla S, Hardison R, Mallios D, Chu D, Wei L, Subramaniam K. Extubating in the operating room after adult cardiac surgery safely improves outcomes and lowers costs. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3101-9.e1. doi: 10.1016/j.jtcvs.2014.07.037. Epub 2014 Jul 31.
PubMed 25173117Subramaniam K, DeAndrade DS, Mandell DR, Althouse AD, Manmohan R, Esper SA, Varga JM, Badhwar V. Predictors of operating room extubation in adult cardiac surgery. J Thorac Cardiovasc Surg. 2017 Nov;154(5):1656-1665.e2. doi: 10.1016/j.jtcvs.2017.05.107. Epub 2017 Jun 13.
PubMed 28711332Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Vender JS, Parikh KN, Patel SS, Patel A. Residual Neuromuscular Block in the Elderly: Incidence and Clinical Implications. Anesthesiology. 2015 Dec;123(6):1322-36. doi: 10.1097/ALN.0000000000000865.
PubMed 26448469Murphy GS, Kopman AF. "To Reverse or Not To Reverse?": The Answer Is Clear! Anesthesiology. 2016 Oct;125(4):611-4. doi: 10.1097/ALN.0000000000001280. No abstract available.
PubMed 27496655Herbstreit F, Zigrahn D, Ochterbeck C, Peters J, Eikermann M. Neostigmine/glycopyrrolate administered after recovery from neuromuscular block increases upper airway collapsibility by decreasing genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2010 Dec;113(6):1280-8. doi: 10.1097/ALN.0b013e3181f70f3d.
PubMed 20980910Boon M, Martini C, Broens S, van Rijnsoever E, van der Zwan T, Aarts L, Dahan A. Improved postoperative oxygenation after antagonism of moderate neuromuscular block with sugammadex versus neostigmine after extubation in 'blinded' conditions. Br J Anaesth. 2016 Sep;117(3):410-1. doi: 10.1093/bja/aew246. No abstract available.
PubMed 27543551Pongracz A, Szatmari S, Nemes R, Fulesdi B, Tassonyi E. Reversal of neuromuscular blockade with sugammadex at the reappearance of four twitches to train-of-four stimulation. Anesthesiology. 2013 Jul;119(1):36-42. doi: 10.1097/ALN.0b013e318297ce95.
PubMed 23665915Paton F, Paulden M, Chambers D, Heirs M, Duffy S, Hunter JM, Sculpher M, Woolacott N. Sugammadex compared with neostigmine/glycopyrrolate for routine reversal of neuromuscular block: a systematic review and economic evaluation. Br J Anaesth. 2010 Nov;105(5):558-67. doi: 10.1093/bja/aeq269. Epub 2010 Oct 8.
PubMed 20935005Park ES, Lim BG, Lee WJ, Lee IO. Sugammadex facilitates early recovery after surgery even in the absence of neuromuscular monitoring in patients undergoing laryngeal microsurgery: a single-center retrospective study. BMC Anesthesiol. 2016 Aug 2;16(1):48. doi: 10.1186/s12871-016-0221-2.
PubMed 27484887Chambers D, Paulden M, Paton F, Heirs M, Duffy S, Craig D, Hunter J, Wilson J, Sculpher M, Woolacott N. Sugammadex for the reversal of muscle relaxation in general anaesthesia: a systematic review and economic assessment. Health Technol Assess. 2010 Jul;14(39):1-211. doi: 10.3310/hta14390.
PubMed 20688009Chambers D, Paulden M, Paton F, Heirs M, Duffy S, Hunter JM, Sculpher M, Woolacott N. Sugammadex for reversal of neuromuscular block after rapid sequence intubation: a systematic review and economic assessment. Br J Anaesth. 2010 Nov;105(5):568-75. doi: 10.1093/bja/aeq270. Epub 2010 Oct 11.
PubMed 20937718Ellison MB, Statler A, Grose B, Sloyer D, Hayanga H, Ellison PR, Funke C. Reversal of neuromuscular blockade after coronary artery bypass grafting: a randomized control trial. BMC Anesthesiol. 2025 Dec 23;25(1):612. doi: 10.1186/s12871-025-03456-6.
PubMed 41437213
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery
- ClinicalTrials.gov ID
- NCT03939923
- Acronym / sponsor ID
- 1806161309
- Conditions
- Surgery, Coronary Artery Disease
- Keywords
- Coronary Artery Bypass Grafting Surgery, Sugammadex
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Posted 22 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine whether the use of Sugammadex will reduce time from reversal to extubation and improve other post extubation outcomes in Coronary artery bypass grafting patients. This study is a prospective, clinical interventional, randomized single blinded single-center design. The nurses in the cardiac intensive care unit will be blinded to treatment allocation (Group 1 or 2).
Detailed description
Enhanced recovery pathways and early extubation of subjects undergoing cardiac procedures has now become mainstay, especially with the advent of minimally invasive procedures .
To facilitate optimal recovery after extubation; muscle strength is vital to prevent reintubation, improved deglutition and quicker transition to lower oxygen requirements, and better respiratory and cardiac hemodynamics. It also expedites de-escalation of acuity of care. Several studies have shown residual muscle weakness after full reversal with neostigmine and glycopyrrolate. Sugammadex is a direct reversal agent and can provide superior muscle strength, which optimizes respiratory function thereby preventing atelectasis, hypoxia and potentially avoiding reintubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015 mg/kg up to 1mg maximal dosage). Group 2 (treatment) will receive reversal with sugammadex 2 mg/kg.
| Arm | Type | Receives |
|---|---|---|
| Neostigmine/Glycopyrrolate | Active comparator | Drug: Rocuronium, Drug: Neostigmine, Drug: GlycopyrrolateGroup 1: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on train of four (TOF) watch monitor reading recorded every 15 minutes. Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage). |
| Sugammadex | Active comparator | Drug: Rocuronium, Drug: SugammadexGroup 2: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on train of four (TOF) watch monitor reading recorded every 15 minutes. Group 2 (treatment) will receive reversal with Sugammadex (2mg/kg). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 - 70 years
- American Society of Anesthesiology physical status I-4
- Isolated coronary artery bypass graft surgery (CABG)
- Ability to give written informed consent
Key exclusion criteria (16 listed)
- Any other surgical procedure concomitant to CABG surgery
- Known or suspected neuromuscular disease/pre-existing weakness
- Creatinine clearance less than 30 ml/min
- Bradycardia of less than 40 beats/min
- Pregnancy, breastfeeding women
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 |
|---|---|---|
| RocuroniumIntubation with Rocuronium 1.0-1.2 mg/kg (vitals maintained within 20% of baseline. Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure. | Drug | Neostigmine/Glycopyrrolate, Sugammadex |
| NeostigmineReversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) | Drug | Neostigmine/Glycopyrrolate |
| GlycopyrrolateReversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage) | Drug | Neostigmine/Glycopyrrolate |
| SugammadexReversal with Sugammadex (2mg/kg) | Drug | Sugammadex |
Primary outcome
Time to Extubation
Time frame: 0 minutes of study drug to 3 days after study drug administration
Time to extubation: West Virginia University Hospitals use an electronic medical record (EMR) to chart "procedure stop." The definition for "time to extubation" is from the time the investigators chart "procedure stop" to the time of "extubation".
5 secondary outcomes
Heart Rate
Time frame: 0 minutes to 2 hours after study drug administration
Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal)
Time frame: 0 minutes to 2 hours after study drug administration
Tidal Volume
Time frame: between 30 minutes to 1 hour after extubation
Peak Flow Rate
Time frame: 30-60 minutes post-extubation
Swallowing Capacity
Time frame: Between 30 and 60 minutes post-extubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25173117Badhwar V, Esper S, Brooks M, Mulukutla S, Hardison R, Mallios D, Chu D, Wei L, Subramaniam K. Extubating in the operating room after adult cardiac surgery safely improves outcomes and lowers costs. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3101-9.e1. doi: 10.1016/j.jtcvs.2014.07.037. Epub 2014 Jul 31.
- Background: PubMed 28711332Subramaniam K, DeAndrade DS, Mandell DR, Althouse AD, Manmohan R, Esper SA, Varga JM, Badhwar V. Predictors of operating room extubation in adult cardiac surgery. J Thorac Cardiovasc Surg. 2017 Nov;154(5):1656-1665.e2. doi: 10.1016/j.jtcvs.2017.05.107. Epub 2017 Jun 13.
- Background: PubMed 26448469Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Vender JS, Parikh KN, Patel SS, Patel A. Residual Neuromuscular Block in the Elderly: Incidence and Clinical Implications. Anesthesiology. 2015 Dec;123(6):1322-36. doi: 10.1097/ALN.0000000000000865.
- Background: PubMed 27496655Murphy GS, Kopman AF. "To Reverse or Not To Reverse?": The Answer Is Clear! Anesthesiology. 2016 Oct;125(4):611-4. doi: 10.1097/ALN.0000000000001280. No abstract available.
- Background: PubMed 20980910Herbstreit F, Zigrahn D, Ochterbeck C, Peters J, Eikermann M. Neostigmine/glycopyrrolate administered after recovery from neuromuscular block increases upper airway collapsibility by decreasing genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2010 Dec;113(6):1280-8. doi: 10.1097/ALN.0b013e3181f70f3d.
- Background: PubMed 27543551Boon M, Martini C, Broens S, van Rijnsoever E, van der Zwan T, Aarts L, Dahan A. Improved postoperative oxygenation after antagonism of moderate neuromuscular block with sugammadex versus neostigmine after extubation in 'blinded' conditions. Br J Anaesth. 2016 Sep;117(3):410-1. doi: 10.1093/bja/aew246. No abstract available.
- Background: PubMed 23665915Pongracz A, Szatmari S, Nemes R, Fulesdi B, Tassonyi E. Reversal of neuromuscular blockade with sugammadex at the reappearance of four twitches to train-of-four stimulation. Anesthesiology. 2013 Jul;119(1):36-42. doi: 10.1097/ALN.0b013e318297ce95.
- Background: PubMed 20935005Paton F, Paulden M, Chambers D, Heirs M, Duffy S, Hunter JM, Sculpher M, Woolacott N. Sugammadex compared with neostigmine/glycopyrrolate for routine reversal of neuromuscular block: a systematic review and economic evaluation. Br J Anaesth. 2010 Nov;105(5):558-67. doi: 10.1093/bja/aeq269. Epub 2010 Oct 8.
- Background: PubMed 27484887Park ES, Lim BG, Lee WJ, Lee IO. Sugammadex facilitates early recovery after surgery even in the absence of neuromuscular monitoring in patients undergoing laryngeal microsurgery: a single-center retrospective study. BMC Anesthesiol. 2016 Aug 2;16(1):48. doi: 10.1186/s12871-016-0221-2.
- Background: PubMed 20688009Chambers D, Paulden M, Paton F, Heirs M, Duffy S, Craig D, Hunter J, Wilson J, Sculpher M, Woolacott N. Sugammadex for the reversal of muscle relaxation in general anaesthesia: a systematic review and economic assessment. Health Technol Assess. 2010 Jul;14(39):1-211. doi: 10.3310/hta14390.
- Background: PubMed 20937718Chambers D, Paulden M, Paton F, Heirs M, Duffy S, Hunter JM, Sculpher M, Woolacott N. Sugammadex for reversal of neuromuscular block after rapid sequence intubation: a systematic review and economic assessment. Br J Anaesth. 2010 Nov;105(5):568-75. doi: 10.1093/bja/aeq270. Epub 2010 Oct 11.
- Derived from this study: PubMed 41437213Ellison MB, Statler A, Grose B, Sloyer D, Hayanga H, Ellison PR, Funke C. Reversal of neuromuscular blockade after coronary artery bypass grafting: a randomized control trial. BMC Anesthesiol. 2025 Dec 23;25(1):612. doi: 10.1186/s12871-025-03456-6.
- Individual participant dataSharing planned: No
Related trials for Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocuronium, Neostigmine and Glycopyrrolate in people with Surgery and Coronary Artery Disease, run by West Virginia University at 1 site 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 4 inclusion and 16 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 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Extubation (time frame: 0 minutes of study drug to 3 days after study drug administration). 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 NCT03939923, which also lists 12 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 27 Dec 2023.