THRIVE Feasibility Trial

Depression Clinical Trial

— THRIVE  

Official title:

Feasibility Study for the Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia (THRIVE) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05346588
• Other study ID #: 202205053
• Status: Completed
• Phase: Phase 3
• Start date: September 29, 2022
• Est. completion date: June 28, 2023

Study information

• Verified date: November 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 28, 2023
• Est. primary completion date: April 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Anesthesia Awareness
• Anesthesia Complication
• Anesthesia Emergence Delirium
• Anesthesia Morbidity
• Depression
• Emergence Delirium
• Intraoperative Awareness
• Nausea, Postoperative
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Quality of Life
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders
• Surgery
• Surgery--Complications

Intervention

Other:
• Anesthetic technique Propofol TIVA
Propofol TIVA no inhaled agent
• Anesthetic technique inhaled agent
must administer inhaled agent.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Hosptial of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Stanford University	Stanford	California

Sponsors (5)

Lead Sponsor	Collaborator
Washington University School of Medicine	Patient-Centered Outcomes Research Institute, Stanford University, University of Michigan, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion participating	Proportion of patients who are approached to participate by the study team and who consent to participate in the study.	8 months
Primary	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).	8 months
Primary	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).	8 months
Secondary	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)	11 months