Propofol vs Inhaled Anesthesia for Surgery

(THRIVE Trial)

Recruiting in Palo Alto (17 mi)

+19 other locations

Overseen by Michael S Avidan, MBBch

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Washington University School of Medicine

Disqualifiers: Pregnancy, Incarceration, Allergy to propofol, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The investigators will conduct a 12,500-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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Propofol for surgery?

Research shows that Propofol is effective for inducing anesthesia in various surgeries, including urological and ophthalmic procedures, providing stable conditions and rapid recovery. It is comparable to other anesthetics like thiopental and Diprivan, with benefits such as reduced intraocular pressure and bronchodilation, making it suitable for patients with respiratory issues. ^{1 2 3 4 5}

How does the drug propofol differ from inhaled anesthesia for surgery?

Propofol is a fast-acting intravenous anesthetic that allows for rapid recovery and clear-headedness after surgery, making it suitable for outpatient procedures. Unlike inhaled anesthetics, propofol is administered through an IV and has a short half-life, which means it is quickly distributed and cleared from the body, reducing the risk of lingering effects. ^{1 2 6 7 8}

Research Team

Michael S Avidan, MBBch

Principal Investigator

Washington University School of Medicine

Sachin Kheterpal, MD

Principal Investigator

University of Michigan

Allison Janda, MD

Principal Investigator

University of Michigan

Mark Neuman, MD

Principal Investigator

University of Pennsylvania

Bethany Pennington, PharmD

Principal Investigator

Washington University School of Medicine

Douglas Colquhoun, MBChB

Principal Investigator

University of Michigan

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I am scheduled for a non-heart surgery under general anesthesia lasting at least 60 minutes.

Exclusion Criteria

I will be on a breathing machine after surgery.

I have had or will have surgery with anesthesia within 30 days around my surgery date.

You have experienced being aware during surgery while under general anesthesia, and you have told someone about it.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Propofol total intravenous anesthesia (TIVA) or inhaled volatile general anesthesia (INVA) during surgery

1 day

1 visit (in-person)

Immediate Postoperative Recovery

Patient recovery experiences are assessed using the QOR15 score on postoperative days 0, 1, 2, and 7

1 week

Follow-up

Participants are monitored for safety and effectiveness, including intraoperative awareness and quality of life assessments

30 days

Extended Follow-up

Long-term follow-up for health-related quality of life and functional status assessments

365 days

Treatment Details

Interventions

• Inhaled agent (Other)
• Propofol TIVA (Other)

Trial Overview 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.

Participant Groups

Group I: Propofol total intravenous anesthesia (TIVA) Active Control 1 Intervention

No administration of inhaled agent.

Group II: inhaled volatile general anesthesia (INVA) Active Control 1 Intervention

Must administer inhaled agent.

Inhaled agent is already approved in Canada for the following indications:

Approved in Canada as Propoven for:

• General anesthesia
• Sedation in intensive care unit

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Arkansas for Medical Sciences (UAMS) Little Rock, AR

University of California San Francisco San Francisco, CA

Stanford University Stanford, CA

Massachusetts General Hospital Boston, MA

More Trial Locations

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2027

Patients Recruited

2,353,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Patients Recruited

27,110,000+

University of Michigan

Collaborator

Trials

1891

Patients Recruited

6,458,000+

Findings from Research

In a study of 40 unpremedicated patients undergoing short urological procedures, propofol was found to have a longer onset of anesthesia and a more significant drop in systolic blood pressure compared to thiopental.

Despite these effects, propofol demonstrated a longer recovery time and less stable heart rate in the thiopental group, but overall, both drugs had similar quality of anesthesia and side effect profiles, indicating that propofol is a suitable option for outpatient surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of anesthesia with propofol in urological outpatient surgery. Katz, Y., Rozenberg, B., Moskovitz, B., et al.[2018]

In a study involving 200 healthy outpatients, the bisulfite-containing formulation of propofol was found to cause less severe pain on injection compared to the brand name Diprivan(TM), with 5% of patients reporting severe pain versus 11% for Diprivan(TM).

Both formulations had similar induction characteristics and safety profiles, making the bisulfite-containing propofol a cost-effective alternative, priced at $13 compared to $15 for Diprivan(TM).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bisulfite-containing propofol: is it a cost-effective alternative to Diprivan for induction of anesthesia? Shao, X., Li, H., White, PF., et al.[2019]

In clinical trials involving 30 studies, Recofol demonstrated a safety profile and efficacy similar to the well-known anesthetic diprivan (propofol), with minimal side effects and low allergenic activity.

Recofol was well tolerated during various surgical procedures, showing consistent hemodynamic and respiratory effects, making it a promising option for anesthesiology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[First experience with clinical use of intravenous anesthetic recofol: effectiveness and safety]. Buniatian, AA., Vabishevich, AV., Flerov, EV., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Propofol for the induction and maintenance of anesthesia in ophthalmic surgery]. Brauneis, S., Collini, S., Pinto, G., et al.[2013]

Propofol is beneficial for patients with chronic respiratory insufficiency as it prevents increased bronchial resistance caused by opioids and has a bronchodilator effect similar to flunitrazepam.

It allows for rapid recovery post-surgery, which can enhance patient cooperation, and is particularly useful in pulmonary surgeries involving one-lung ventilation without depressing the hypoxic vasoconstriction reflex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of Diprivan in chronic respiratory insufficiency]. Bourgain, JL.[2019]

Propofol is a fast-acting intravenous anesthetic with a very short half-life of about 2 minutes, making it ideal for quick induction of anesthesia and outpatient procedures due to its rapid recovery and minimal hangover effects.

While propofol can cause more cardiorespiratory depression compared to other agents, it does not increase heart rate, which helps manage cardiac oxygen demands, making it a suitable option for patients with cardiac conditions, although caution is advised in the elderly due to increased sensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propofol, the newest induction agent of anesthesia. Kanto, JH.[2013]

In a study of 212 patients (103 with cancer and 109 without), total propofol consumption was lower in cancer patients (85.86 mcg/kgBW/min) compared to non-cancer patients (95.77 mcg/kgBW/min), indicating that cancer status influences propofol dosing during surgery.

Despite differences in propofol consumption, recovery time did not significantly differ between cancer and non-cancer patients, suggesting that the anesthetic management is similarly effective in both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propofol doses differ in total intravenous anaesthesia (TIVA) for cancer and no cancer surgery - observational cohort study. Pejakov, L., Ždralević, M., Đurišić, I.[2022]

This study will compare the effects of propofol and sevoflurane on the incidence of postoperative delirium in 298 elderly patients undergoing spine surgery, aiming to determine which anesthetic may reduce delirium risk.

The primary outcome is the incidence of delirium within 7 days post-surgery, with secondary outcomes including the timing and duration of delirium, recovery metrics, and other postoperative complications, which could guide better anesthesia choices for elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of propofol versus sevoflurane on the incidence of postoperative delirium in elderly patients after spine surgery: study protocol of a randomized controlled trial. Wang, JH., Lv, M., Zhang, HX., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Induction of anesthesia with propofol in urological outpatient surgery. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Bisulfite-containing propofol: is it a cost-effective alternative to Diprivan for induction of anesthesia? [2019]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[First experience with clinical use of intravenous anesthetic recofol: effectiveness and safety]. [2018]

4. Italy pubmed.ncbi.nlm.nih.gov

[Propofol for the induction and maintenance of anesthesia in ophthalmic surgery]. [2013]

5. France pubmed.ncbi.nlm.nih.gov

[Use of Diprivan in chronic respiratory insufficiency]. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Propofol, the newest induction agent of anesthesia. [2013]

7. Italy pubmed.ncbi.nlm.nih.gov

Propofol doses differ in total intravenous anaesthesia (TIVA) for cancer and no cancer surgery - observational cohort study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Impact of propofol versus sevoflurane on the incidence of postoperative delirium in elderly patients after spine surgery: study protocol of a randomized controlled trial. [2022]