Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor: Washington University School of Medicine
Study ID: NCT05991453
Status: Recruiting

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Conditions

Anesthesia
Anesthesia Awareness
Anesthesia Complication
Anesthesia Morbidity
Pain, Postoperative
Quality of Life
Surgery
Surgery-Complications

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Anesthetic technique Propofol TIVA — OTHER
Propofol TIVA no inhaled agent
Anesthetic technique inhaled agent — OTHER
Must administer inhaled agent.

Study Details

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

Key Dates

Start date: Sep 13, 2023
Status verified: Jul 2025
Primary completion: Jul 31, 2027
Completion: Jul 31, 2028

Study Design

Enrollment: 13,000 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Arms

Active Comparator: Propofol total intravenous anesthesia (TIVA)
No administration of inhaled agent.
Active Comparator: inhaled volatile general anesthesia (INVA)
Must administer inhaled agent.

Primary Outcome Measure

Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery [ Time Frame: Postoperative day 1 ]

Central Contacts

Laura Swisher
314-286-1024
[email protected]
Sherry McKinnon
314-286-1024
[email protected]

Locations (20)

Facility	City	State	ZIP	Site coordinators
University of Arkansas for Medical Sciences (UAMS)	Little Rock	Arkansas	72205	Geoffrey Muller, MD [email protected] Gwendolyn Cobbs Cobbs [email protected] Geoffrey Muller, MD (PRINCIPAL_INVESTIGATOR)
University of California San Francisco	San Francisco	California	94143	Lee-lynn Chen, MD [email protected] Neil Panchal [email protected] Lee-lynn Chen, MD (PRINCIPAL_INVESTIGATOR) Matthieu Legrand, MD (PRINCIPAL_INVESTIGATOR) Jeremy Juang, MD (PRINCIPAL_INVESTIGATOR) Jennifer Woodbury, MD (PRINCIPAL_INVESTIGATOR)
Stanford University	Stanford	California	94305	David Drover, MD [email protected] Samantha Gaston [email protected] David Drover, MD (PRINCIPAL_INVESTIGATOR)
Yale School of Medicine	New Haven	Connecticut	06510	Jaime B Hyman, MD [email protected] Andrew Shapiro [email protected] Jaime B Hyman, MD (PRINCIPAL_INVESTIGATOR) Robert B Schonberger, MD (SUB_INVESTIGATOR)
Brigham & Women's	Boston	Massachusetts	02115	Luigino Nascimben, MD [email protected] Sula Nasra [email protected] Luigino Nascimben, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital	Boston	Massachusetts	02114	Amit Bardia, MD [email protected] Ariel Mueller, MA [email protected] Amit Bardia, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan	Ann Arbor	Michigan	48109	Allison Janda, MD [email protected] Rachel Shoemake [email protected] Sachin Kheterpal, MD (PRINCIPAL_INVESTIGATOR) Allison Janda, MD (PRINCIPAL_INVESTIGATOR) Sathish Kumar, MD (SUB_INVESTIGATOR)
Henry Ford Health	Detroit	Michigan	48202	Anoop Chhina, MD [email protected] Katherine Nowak, PhD [email protected] Anoop Chhina, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of Medicine	St Louis	Missouri	63110	Laura Swisher [email protected] Sherry McKinnon, MS [email protected] Michael S Avidan, MBBch (PRINCIPAL_INVESTIGATOR) Stephen Gregory, MD (PRINCIPAL_INVESTIGATOR)
Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	03756	Stacie Deiner, MD [email protected] Stacie Deiner, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone	New York	New York	10012	Simon Tom, MD [email protected] Lola Franco [email protected] Simon Tom, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medicine	New York	New York	10065	Kane O Pryor, MD [email protected] Jay Sangwan [email protected] Kane O Pryor, MD (PRINCIPAL_INVESTIGATOR)
Duke University	Durham	North Carolina	27708	Kam Ghadimi, MD [email protected] Kelly Rodden, BSN [email protected] Kam Ghadimi, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest	Winston-Salem	North Carolina	27109	Ashish Khanna, MD [email protected] Amelia Eaton [email protected] Ashish Khanna, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Sciences University	Portland	Oregon	97239	Michael Aziz, MD [email protected] Sarah Feller [email protected] Michael Aziz, MD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania	Philadelphia	Pennsylvania	19104	Caoimhe Duffy, MD [email protected] Karah Whatley [email protected] Caoimhe Duffy, MD (PRINCIPAL_INVESTIGATOR)
University of Texas - MD Anderson	Houston	Texas	77030	Juan Cata, MD [email protected] Paloma Aveni Strafile, MD [email protected] Juan Cata, MD (PRINCIPAL_INVESTIGATOR)
University of Utah - Medical	Salt Lake City	Utah	84132	Ken Johnson, MD [email protected] Anne Mackey, MD [email protected] Ken Johnson, MD (PRINCIPAL_INVESTIGATOR)
UVA Health	Charlottesville	Virginia	22908	Bhiken Naik, MD [email protected] Keita Ikeda, PhD [email protected] Bhiken Naik, MD (PRINCIPAL_INVESTIGATOR)
University of Washington	Seattle	Washington	98195	Karen Domino, MD [email protected] Shawn Mincer [email protected] Karen Domino, MD (PRINCIPAL_INVESTIGATOR)

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By research site

University of Arkansas for Medical Sciences (UAMS)· Little Rock, AR University of California San Francisco· San Francisco, CA Stanford University· Stanford, CA Yale School of Medicine· New Haven, CT Brigham & Women's· Boston, MA Massachusetts General Hospital· Boston, MA

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