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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
Must not have
Planned postoperative intubation
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 - 7 days prior to surgery
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I will be on a breathing machine after surgery.
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I have had or will have surgery with anesthesia within 30 days around my surgery date.
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I need a special type of anesthesia for my surgery due to specific monitoring.
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I cannot use propofol due to an allergy, severe nausea, or a history of malignant hyperthermia.
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I can provide informed consent in English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of definite intraoperative awareness with recall
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after minor inpatient surgery
+1 more
Secondary study objectives
All-Cause Mortality at POD30
All-Cause Mortality at POD90
Days Alive and at Home at 30 days after major inpatient surgery
+53 more
Other study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
579 Previous Clinical Trials
27,075,259 Total Patients Enrolled
5 Trials studying Infections
94,952 Patients Enrolled for Infections
Washington University School of MedicineLead Sponsor
2,000 Previous Clinical Trials
2,331,762 Total Patients Enrolled
38 Trials studying Infections
23,432 Patients Enrolled for Infections
University of MichiganOTHER
1,863 Previous Clinical Trials
6,429,073 Total Patients Enrolled
24 Trials studying Infections
69,666 Patients Enrolled for Infections
Bethany Pennington, PharmDStudy DirectorWashington University School of Medicine
Allison Janda, MDStudy DirectorUniversity of Michigan
Mark Neuman, MDStudy DirectorUniversity of Pennsylvania
1 Previous Clinical Trials
3,548 Total Patients Enrolled
Michael S Avidan, MBBChPrincipal InvestigatorWashington University School of Medicine
7 Previous Clinical Trials
115,434 Total Patients Enrolled
Douglas Colquhoun, MBChBStudy DirectorUniversity of Michigan
Michael S Avidan, MBBcHPrincipal InvestigatorWashington University School of Medicine
3 Previous Clinical Trials
9,360 Total Patients Enrolled
Sachin Kheterpal, MDPrincipal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
300 Total Patients Enrolled

Media Library

Inhaled agent (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05991453 — N/A
Infections Research Study Groups: Propofol total intravenous anesthesia (TIVA), inhaled volatile general anesthesia (INVA)
Infections 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
~8333 spots leftby Jul 2027
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