Etomidate vs Propofol for Anesthesia in Major Surgery

Enrolling by invitation at 11 trial locations

Overseen By Fabio Rodriquez Patarroyo, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The University of Texas Health Science Center, Houston

Must be taking: Antihypertensives

Disqualifiers: Carotid, Intracranial, Nephrectomy, Liver, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: During surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two drugs, etomidate and propofol, to determine which provides better anesthesia during major surgery. The goal is to identify the drug that offers safer and more effective anesthesia. Participants will join one of four groups, each trying a different combination of blood pressure management and anesthetic. Individuals who have undergone major non-heart-related surgeries and plan to stay in the hospital overnight may qualify. Those with certain health conditions, such as diabetes, a history of heart issues, or who smoke, could also be eligible. As a Phase 4 trial, this research aims to understand how these FDA-approved and effective treatments can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be taking at least one anti-hypertensive medication to participate.

What is the safety track record for these treatments?

Previous studies have shown that etomidate is quite safe for use in anesthesia. It helps maintain stable blood pressure during surgery and has only minor effects on the heart and blood vessels. It does not increase the risk of complications after surgery, even in older patients, and it did not affect the 30-day survival rate after heart surgery compared to other drugs.

Propofol is also commonly used for anesthesia and is generally safe, though it might cause a drop in blood pressure during surgery. Some studies have compared it to ciprofol, which showed similar success rates but better blood pressure stability. Despite this, propofol remains a trusted choice for many surgeries.

Both etomidate and propofol are well-tolerated by patients and are regularly used in surgeries, indicating their safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about comparing Etomidate and Propofol for anesthesia in major surgery because they want to see which drug offers better control over blood pressure management during procedures. Both drugs are commonly used for anesthesia induction, but they affect the cardiovascular system differently. Etomidate is known for maintaining stable blood pressure, which can be crucial in high-risk surgeries. Meanwhile, Propofol is favored for its rapid onset and quick recovery times. By evaluating these drugs under different blood pressure management strategies, researchers hope to optimize anesthesia protocols for patient safety and outcomes.

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

This trial will compare Etomidate and Propofol for anesthesia induction in major surgery. Research has shown that both etomidate and propofol are effective for initiating anesthesia during major surgery. Studies suggest that etomidate, administered to participants in some trial arms, is safer for the heart, causing fewer heart-related issues than other drugs. It also does not increase postoperative complications in older patients compared to propofol. Conversely, propofol, given to participants in other trial arms, is associated with a smooth recovery and higher patient satisfaction. However, it may reduce survival chances in some critically ill patients, making it essential to weigh the pros and cons. Overall, both drugs are commonly used and effective, each offering distinct benefits and risks. ^{3 4 6 7 8}

Who Is on the Research Team?

Daniel Sessler, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults over 45 who need major noncardiac surgery lasting at least 2 hours and will stay in the hospital overnight. They must have certain risk factors like being over 65, having a history of heart or artery disease, diabetes, smoking history, high body mass index (BMI), or specific blood markers indicating heart stress.

Inclusion Criteria

I expect to stay in the hospital overnight or longer.

I am over 65, have had vascular surgery, or have certain health conditions.

I will have my blood pressure monitored directly during surgery.

Exclusion Criteria

I cannot take norepinephrine or phenylephrine due to my doctor's advice.

I am scheduled for a liver transplant.

I am scheduled for surgery on my carotid artery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either etomidate or propofol for induction of anesthesia, along with routine or tight intraoperative blood pressure management

During surgery

Postoperative Monitoring

Participants are monitored for postoperative delirium and other complications during the initial four postoperative days

4 days

Follow-up

Participants are monitored for serious perfusion-related complications and other outcomes

30 days

Long-term Follow-up

Participants are assessed for cognition and major adverse cardiac events

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Etomidate
• Propofol

Trial Overview The study tests two anesthetic drugs—Etomidate and Propofol—used during surgery to see which one better maintains blood pressure when combined with either routine or tight blood pressure control methods in patients undergoing major surgeries.

How Is the Trial Designed?

Group I: Routine Blood Pressure Management and Etomidate Induction Active Control 2 Interventions

Etomidate will be used as the anesthetic induction agent.

Group II: Routine Blood Pressure Management and Propofol Induction Active Control 2 Interventions

Propofol will be used as the anesthetic induction agent.

Group III: Tight Blood Pressure Management and Etomidate Induction Active Control 2 Interventions

Etomidate will be used as the anesthetic induction agent.

Group IV: Tight Blood Pressure Management and Propofol Induction Active Control 2 Interventions

Propofol will be used as the anesthetic induction agent.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

In a study of 1,462 cardiac surgery patients, etomidate did not significantly increase the risk of postoperative sepsis compared to propofol, with rates of 11.5% for etomidate versus 8.2% for propofol (p = 0.052).

However, patients receiving etomidate were more likely to develop hospital-acquired pneumonia (18.6% vs. 14.0% for propofol, p = 0.031), indicating a potential safety concern with etomidate use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infectious Complications after Etomidate vs. Propofol for Induction of General Anesthesia in Cardiac Surgery-Results of a Retrospective, before-after Study. Weiss, B., Schiefenhövel, F., Grunow, JJ., et al.[2021]

In a study of 25 patients undergoing elective orthopedic surgeries, Etomidate demonstrated more stable hemodynamic responses compared to Propofol, with significantly lower changes in blood pressure and a lower incidence of hypotension (8% vs. 26.1%).

The findings suggest that Etomidate may be a safer choice for patients with limited hemodynamic reserve, as it maintains cardiovascular stability better than Propofol during anesthesia induction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of cardiovascular response to laryngoscopy and tracheal intubation after induction of anesthesia by Propofol and Etomidate. Masoudifar, M., Beheshtian, E.[2021]

In a study of 214 patients undergoing procedural sedation in the emergency department, both etomidate and propofol were found to be equally safe, with no clinically significant complications reported.

However, etomidate was associated with a lower procedural success rate (88.6%) compared to propofol (97.2%) and caused myoclonus in 20% of patients, indicating potential drawbacks despite its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of etomidate versus propofol for procedural sedation in the emergency department. Miner, JR., Danahy, M., Moch, A., et al.[2022]

In a study of 100 patients undergoing elective surgery, etomidate demonstrated better hemodynamic stability compared to propofol, with minimal changes in mean arterial pressure and heart rate during induction.

While propofol caused more pain upon injection, etomidate was associated with higher instances of myoclonus, suggesting that etomidate may be a safer choice for hemodynamically unstable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study between propofol and etomidate in patients under general anesthesia. Aggarwal, S., Goyal, VK., Chaturvedi, SK., et al.[2022]

In a study of 100 patients undergoing elective surgery, etomidate demonstrated better hemodynamic stability compared to propofol, with minimal changes in mean arterial pressure and heart rate during induction.

While propofol was associated with more pain on injection, etomidate resulted in higher instances of myoclonus, suggesting that etomidate may be a safer choice for hemodynamically unstable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A comparative study between propofol and etomidate in patients under general anesthesia]. Aggarwal, S., Goyal, VK., Chaturvedi, SK., et al.[2016]

Etomidate demonstrated a superior haemodynamic profile compared to propofol, causing a 34% lesser reduction in mean arterial blood pressure (MAP) after induction of anaesthesia in patients undergoing cardiac surgery, based on a study of 150 participants.

Despite propofol being associated with a greater reduction in MAP, the use of vasopressors was not significantly different between the two groups, indicating that etomidate may be a safer option for maintaining blood pressure during anaesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haemodynamic profiles of etomidate vs propofol for induction of anaesthesia: a randomised controlled trial in patients undergoing cardiac surgery. Hannam, JA., Mitchell, SJ., Cumin, D., et al.[2019]

In a study of 128 patients undergoing endoscopic procedures, etomidate was associated with significantly fewer cases of oxygen desaturation (6.25% vs 31.25%) and respiratory depression (7.81% vs 32.81%) compared to propofol, indicating better respiratory safety.

While etomidate showed improved respiratory outcomes and higher physician satisfaction, it was linked to a higher incidence of myoclonus (34.37% vs 12.50%) and increased systolic blood pressure, suggesting a trade-off in its use for sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etomidate versus propofol sedation for complex upper endoscopic procedures: a prospective double-blinded randomized controlled trial. Kim, MG., Park, SW., Kim, JH., et al.[2018]

In a study of 12,526 critical care patients, those administered etomidate had a 1.84 times higher risk of in-hospital mortality compared to those given propofol, indicating significant safety concerns.

Etomidate was associated with a 57% lower chance of survival within the first 48 hours and a 1.77 times higher risk of infectious complications, suggesting it is not an effective choice for patients on mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of etomidate use in ICU patients on ventilator therapy: a study of 12,526 patients in an open database from a single center. Park, HY., Lee, Y., Lim, CY., et al.[2022]

Etomidate is an intravenous anesthetic that is considered safe for use in patients at high risk of hemodynamic instability, but it can cause temporary suppression of adrenal function, which may increase mortality in septic patients.

Current literature does not provide strong evidence against using a single-bolus dose of etomidate for induction in surgical patients, indicating that more large-scale randomized controlled trials are needed to fully assess its safety compared to other anesthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etomidate--a review of robust evidence for its use in various clinical scenarios. Erdoes, G., Basciani, RM., Eberle, B.[2022]

In a study of 1018 patients undergoing radical gastric cancer surgery, those who received propofol had significantly longer survival times compared to those who received etomidate, particularly in TNM stage IIIA and IIIC patients.

Specifically, patients in TNM stage IIIA had survival times of 41.79 months with propofol versus 36.10 months with etomidate, and in stage IIIC, survival times were 35.20 months with propofol compared to 26.57 months with etomidate, indicating that propofol may enhance postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Propofol or Etomidate as General Anaesthesia Induction on Gastric Cancer: A Retrospective Cohort Study with 10 Years' Follow-Up. Lu, X., Yu, Y., Wang, Y., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11585772/

Comparison of efficacy and safety of etomidate with other ... Etomidate did not affect the all-cause 30-day mortality of patients undergoing cardiac surgery compared to comparator drugs.

2. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2795109

Effect of Etomidate vs Propofol for Total Intravenous ... Findings of this trial indicate that etomidate anesthesia does not increase postoperative morbidity in older patients compared with propofol.

3. atsjournals.org atsjournals.org/doi/full/10.1164/rccm.202404-0813OC

Evaluation of Etomidate Use and Association with Mortality ... Measurements and Main Results: Of 1,689,945 patients who received IMV, nearly half (738,855; 43.7%) received etomidate. Among those who received ...

4. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-014-0560-7

Etomidate for anesthesia induction: friends or foe in major ... There are no convincing or consistent data from evidence-based medicine that etomidate is associated with poor outcome, especially increased ...

5. researchprotocols.org researchprotocols.org/2024/1/e55948

Efficacy and Safety of Remimazolam Versus Etomidate for ... Etomidate is considered a safer drug for the induction of anesthesia because it has only minor adverse effects on the cardiovascular and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024143058

Comparison of efficacy and safety of etomidate with other ... They observed that a single dose of etomidate administered during anesthetic induction was associated with improved hemodynamic stability, and although it led ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39584115

Comparison of efficacy and safety of etomidate with other ... Etomidate did not affect the all-cause 30-day mortality of patients undergoing cardiac surgery compared to comparator drugs (RR, 0.96; 95 % CI, ...

8. cell.com cell.com/heliyon/pdf/S2405-8440(24)14305-8.pdf

Comparison of efficacy and safety of etomidate with other ... They observed that a single dose of etomidate administered during anesthetic induction was associated with improved hemodynamic stability, and ...