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Propofol vs Inhaled Anesthesia for Surgery (THRIVE Trial)

N/A
Recruiting
Led By Michael S Avidan, MBBcH
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia with a tracheal tube or laryngeal mask airway (or similar supra-glottic device)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 - 34 days after surgery
Awards & highlights

THRIVE Trial Summary

This trial will compare two anesthesia techniques to see which yields better patient recovery outcomes and any potential risks.

Who is the study for?
This trial is for adults aged 18+ who are having elective non-cardiac surgery lasting at least an hour with general anesthesia. It's not for those unable to consent in English/Spanish, pregnant women, recent or soon-to-have other surgeries under anesthesia, or if they have allergies to the study drugs or conditions like malignant hyperthermia.Check my eligibility
What is being tested?
The trial compares two types of general anesthesia: Propofol TIVA (total intravenous anesthesia) and INVA (inhaled volatile agents), across three surgical categories. The goal is to see which method offers better recovery experiences and ensure that TIVA doesn't significantly increase the risk of being aware during surgery.See study design
What are the potential side effects?
Possible side effects include typical reactions to anesthesia such as nausea, vomiting, sore throat from the breathing tube or mask, drowsiness after surgery, muscle aches, confusion upon waking up from the anesthesia and less commonly intraoperative awareness.

THRIVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a non-heart surgery under general anesthesia lasting at least 60 minutes.

THRIVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 - 7 days prior to surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 - 7 days prior to surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of unintended intraoperative awareness with recall on POD1 or POD30
Quality of Recovery-15 (QOR 15) score on POD1 after Major inpatient surgery
Quality of Recovery-15 score on POD1 after Outpatient surgery
+1 more
Secondary outcome measures
Bauer Questionnaire - Patient satisfaction with anesthesia at POD2
Days alive and at-home at POD30 after major inpatient surgery
Days alive and at-home at POD30 after minor inpatient surgery
+41 more
Other outcome measures
Daily standing hours as measured by wearable device at baseline for those scheduled for major inpatient surgery.
Daily standing hours as measured by wearable device at baseline for those scheduled for minor inpatient surgery.
Daily standing hours as measured by wearable device at baseline for those scheduled for outpatient surgery.
+36 more

THRIVE Trial Design

2Treatment groups
Active Control
Group I: Propofol total intravenous anesthesia (TIVA)Active Control1 Intervention
No administration of inhaled agent.
Group II: inhaled volatile general anesthesia (INVA)Active Control1 Intervention
Must administer inhaled agent.

Find a Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,984,958 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,287,195 Total Patients Enrolled
2 Trials studying Postoperative Pain
333 Patients Enrolled for Postoperative Pain
University of MichiganOTHER
1,798 Previous Clinical Trials
6,365,638 Total Patients Enrolled

Media Library

Inhaled agent (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05991453 — N/A
Postoperative Pain Research Study Groups: Propofol total intravenous anesthesia (TIVA), inhaled volatile general anesthesia (INVA)
Postoperative Pain Clinical Trial 2023: Inhaled agent Highlights & Side Effects. Trial Name: NCT05991453 — N/A
Inhaled agent (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05991453 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts still underway for this trial?

"As per the information available on clinicaltrials.gov, this study — which first appeared online on August 1st 2023 and was last updated 7 days later — is no longer seeking new participants; however, there are 2390 other medical trials that require subjects at present."

Answered by AI

What is the primary aim of this investigation?

"This evaluation, which records data between baseline and day one, is meant to measure the Quality of Recovery-15 score for patients undergoing minor inpatient surgery on POD1. Additionally, a comparison will be made between their QOR scores from before and after outpatient surgery (POD0), as well as major inpatient operations taken at POD2. The higher the given score out of 150 points, the more likely it is that they have returned back to their pre-surgery level of quality."

Answered by AI
~8333 spots leftby Jul 2027