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General Anesthetic
Etomidate vs Propofol for Anesthesia in Major Surgery
Phase 3
Recruiting
Led By Daniel I Sessler, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Expected to require at least overnight hospitalization (planned ICU admission is acceptable)
Expected to have direct intraoperative blood pressure monitoring with an arterial catheter
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will compare two drugs used for anesthesia induction to see which is better.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects from Etomidate include temporary adrenal insufficiency and muscle movements. Propofol can cause low blood pressure, pain at the injection site, and may lead to a rare but serious condition called propofol infusion syndrome.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I expect to stay in the hospital overnight or longer.
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I will have my blood pressure monitored directly during surgery.
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I will be undergoing surgery with general or spinal anesthesia.
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I am on long-term blood pressure medication.
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I am scheduled for a major surgery that is not heart-related and will last at least 2 hours.
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I am at least 45 years old.
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I have a serious health condition that affects my daily life.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite of serious perfusion-related complications
Secondary outcome measures
Cognition
Major Adverse cardiac events
Postoperative Delirium
Other outcome measures
Atrial Fibrillation
Hospital Readmission
ICU admission
Trial Design
4Treatment groups
Active Control
Group I: Routine Pressure Management with etomidate inductionActive Control2 Interventions
Etomidate will be used as an induction agent.
Group II: Routine Pressure Management with propofol inductionActive Control2 Interventions
Propofol will be used as an induction agent.
Group III: Tight Pressure Management with etomidate inductionActive Control2 Interventions
Etomidate will be used as an induction agent.
Group IV: Tight Pressure Management with propofol inductionActive Control2 Interventions
Propofol will be used as an induction agent.
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,027 Previous Clinical Trials
1,358,024 Total Patients Enrolled
1 Trials studying Major Surgery
200 Patients Enrolled for Major Surgery
Daniel I Sessler, MDPrincipal InvestigatorThe Cleveland Clinic
33 Previous Clinical Trials
91,034 Total Patients Enrolled
1 Trials studying Major Surgery
200 Patients Enrolled for Major Surgery
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I will be undergoing surgery with general or spinal anesthesia.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.I am scheduled for a surgery to remove part or all of my kidney.I am scheduled for brain surgery.I am scheduled for surgery to remove a pheochromocytoma.I am on long-term blood pressure medication.I need to be seated in a beach-chair position for my procedure.My doctor has advised against strict blood pressure control due to my condition.I am scheduled for a major surgery that is not heart-related and will last at least 2 hours.I am at least 45 years old.I have a serious health condition that affects my daily life.I am on dialysis or my kidneys filter blood very poorly.I need medicine through an IV to help control my blood pressure before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Routine Pressure Management with etomidate induction
- Group 2: Routine Pressure Management with propofol induction
- Group 3: Tight Pressure Management with etomidate induction
- Group 4: Tight Pressure Management with propofol induction
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people who suffer from the same condition as me able to participate in this research project?
"From what is posted on clinicaltrials.gov, this research is currently looking for individuals to take part in the study. The trial was originally posted on 7/27/2021 and the last edit was 9/16/2022."
Answered by AI
What types of medical conditions does Tight Pressure Management with propofol induction help to alleviate?
"Propofol induction with tight pressure management is commonly used to treat sedative therapy. However, it can also be used for general anesthesia, sedation during medical procedures, and other anesthesia procedures."
Answered by AI
What is the Tight Pressure Management with propofol induction's official stance from the FDA?
"There is some evidence to support the efficacy of Tight Pressure Management with propofol induction, as this is a Phase 3 trial. Furthermore, multiple rounds of data support the safety of this intervention, so our team at Power has given it a score of 3."
Answered by AI
Are Tight Pressure Management and propofol induction commonly used in other medical studies?
"80 Tight Pressure Management with propofol induction studies are currently underway. 12 of those are in the critical third Phase. Although a majority of the Tight Pressure Management with propofol induction studies are based in Jinan, Shandong, there are 262 research locations in total."
Answered by AI
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