Clinical trial NCT05346588: THRIVE Feasibility Trial
Official title: Feasibility Study for the Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia (THRIVE) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgery--Complications
Anesthesia Complication
Anesthesia Awareness
Anesthesia Emergence Delirium
Anesthesia
Surgery
Quality of Life
Pain, Postoperative
Nausea, Postoperative
Anesthesia Morbidity
Depression
Sleep Disorders, Circadian Rhythm
Keywords: Quality of recovery
Intraoperative awareness
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: University of Pennsylvania
name: Stanford University
name: Patient-Centered Outcomes Research Institute
First posted: 2022-04-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion participating
timeFrame: 8 months
measure: Proportion receiving TIVA
timeFrame: 8 months
measure: Proportion receiving inhaled anesthesia
timeFrame: 8 months
Secondary outcomes:
measure: Completeness of data collection
timeFrame: 11 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Philadelphia
country: United States
facility: Hosptial of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Michigan
name: Sachin Kheterpal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington Univeristy
name: Michael S Avidan, MBBcH
role: PRINCIPAL_INVESTIGATOR
References: