Propofol vs Inhaled Anesthesia for Surgery

(THRIVE Trial)

Recruiting at 21 trial locations

Overseen By Sherry McKinnon

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Pregnancy, Incarceration, Allergy to propofol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

13000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to aid recovery after surgery by comparing inhaled anesthesia and propofol total intravenous anesthesia (TIVA). The goal is to determine which method provides a better recovery experience and to ensure that TIVA does not significantly increase the risk of intraoperative awareness. The trial includes individuals aged 18 and older undergoing elective surgeries lasting at least an hour and requiring general anesthesia. As an unphased trial, it offers participants the chance to contribute to important research that could enhance surgical recovery experiences for future patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using Propofol in total intravenous anesthesia (TIVA) is generally safe for patients. Studies have found that TIVA can shorten surgeries and lead to fewer complications compared to other methods. Importantly, TIVA matches inhaled anesthesia in safety regarding key outcomes like survival and organ health.

Inhaled anesthesia is also safe and commonly used, though it can sometimes cause issues like increased eye pressure or changes in heart rhythm. The FDA has approved inhaled anesthetics, confirming their safety through testing.

Both Propofol TIVA and inhaled anesthesia have their pros and cons. Research supports that both are well-tolerated, making them viable options for anesthesia during surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing Propofol total intravenous anesthesia (TIVA) and inhaled volatile general anesthesia (INVA) because it aims to uncover differences in how these two anesthesia methods work for surgery. Unlike traditional inhaled anesthetics that require vaporized agents breathed in by patients, Propofol TIVA is administered directly into the bloodstream, potentially offering more precise control over anesthesia levels. This could lead to faster recovery times and fewer side effects compared to inhaled agents. Understanding these distinctions could lead to improved surgical experiences and outcomes for patients.

What evidence suggests that this trial's treatments could be effective for surgery?

This trial will compare Propofol total intravenous anesthesia (TIVA) with inhaled volatile general anesthesia (INVA) for surgery. Research has shown that Propofol TIVA can improve recovery and reduce the risk of confusion and nausea after surgery. One study found that surgeries and anesthesia times were shorter with Propofol TIVA compared to other methods. Additionally, Propofol is as safe and effective as other anesthetics.

For inhaled anesthesia, studies suggest it may help reduce inflammation during surgery. Inhaled anesthetics effectively cause memory loss and keep patients still during surgery. Both Propofol TIVA and inhaled anesthesia offer benefits and are effective for surgery. ^{2 5 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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 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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Inhaled agent
• Propofol TIVA

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Diprivan for:

• Induction and maintenance of general anesthesia
• Sedation in intensive care unit

Approved in European Union as Propofol for:

• General anesthesia
• Sedation in intensive care unit

Approved in Canada as Propoven for:

• General anesthesia
• Sedation in intensive care unit

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

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]

Propofol (diisopropylphenol) significantly reduces intraocular pressure (IOP) during the induction of anesthesia for ophthalmic surgery, making it a beneficial choice over thiopental sodium (TPS).

Continuous infusion of propofol (Diprivan) offers satisfactory conditions for intraocular surgery, suggesting it could be a preferable alternative to thiopental combined with enflurane.

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12440536/

Effect of Inhaled Volatile and IV Anesthetics on Biological ... Inhaled anesthetics may reduce alveolar and systemic inflammation in surgical and critically ill patients. This study aimed to perform a ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK554540/

Inhalational Anesthetic - StatPearls - NCBI Bookshelf - NIH All inhalational anesthetics provide amnesia and immobility, except for nitrous oxide, which also provides analgesia. Inhaled anesthetics are ...

3. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00215-3/fulltext

Mortality and morbidity after total intravenous anaesthesia ... We aimed to summarise all available evidence on relevant patient outcomes with total intravenous anaesthesia versus inhalational anaesthesia.

4. asahq.org asahq.org/about-asa/governance-and-committees/asa-committees/environmental-sustainability/greening-the-operating-room/inhaled-anesthetics

Environmental Impact of Inhaled Anesthetics In clinical contexts, inhaled anesthetics can account for 50% of perioperative emissions,88 5% of emissions from hospitals,69 and 3% of total national health ...

5. atsjournals.org atsjournals.org/doi/10.1164/rccm.201512-2435CP

Volatile Anesthetics. Is a New Player Emerging in Critical ... Research has demonstrated that volatile-based sedation may provide superior awakening and extubation times in comparison with current intravenous sedation ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK541090/

Anesthesia Inhalation Agents and Their Cardiovascular Effects Potential complications of inhaled anesthetics include prolonged QT interval and increased intraocular pressure. Compared to intravenous ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2957391224000834

The environmental effects of anesthetic agents and ... Increasing the use of total intravenous anesthesia (TIVA) in surgical settings can decrease the use and harmful environmental effects of inhaled volatiles like ...

8. journals.lww.com journals.lww.com/ccejournal/fulltext/2025/07000/effect_of_inhaled_volatile_and_iv_anesthetics_on.5.aspx

Effect of Inhaled Volatile and IV Anesthetics on Biological .. ... Inhaled anesthetics may reduce alveolar and systemic inflammation in surgical and critically ill patients. This study aimed to perform a systematic review ...