Etomidate Combined With PropofolNCT07019246
Safety of Etomidate-propofol Mixture vs. Propofol for Total Intravenous Anesthesia in Elderly Patients Undergoing Abdominal Surgery
A study testing EP mixture and Propofol in people with Etomidate Combined With Propofol and Hypertension, run by Tongji Hospital at 1 site in China.
Trial summary
The purpose of this study is to access the safety of etomidate - propofol mixture vs propofol for total intravenous anesthesia in elderly patients undergoing abdominal surgery. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Etomidate Combined With Propofol, Hypertension
- What is being tested?
- EP mixture and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ASA Ⅰ~Ⅲ;
- BMI was 18-28 kg/m2;
- For elective abdominal surgery under intravenous general anesthesia;
- The expected duration of anesthesia was 1 to 4 hours.
Who cannot join
- Septic shock and multiple organ failure diagnosed within 14 days;
- Hyperkalemia (serum potassium >5.5mmol/L) within 48 hours;
- Stroke or transient ischemic attack within 3 months;
- Patients with unstable angina pectoris or myocardial infarction within 3 months; Arrhythmia requiring treatment was not treated or treatment did not meet expectations;
- Patients with preoperative diagnosed diabetes mellitus and uncontrolled blood glucose; Diabetic complications were diagnosed before surgery, including diabetic ketoacidosis, hyperosmolar coma, diabetes-related infection, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.
- Severe liver and renal dysfunction;
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- Liver surgery, renal surgery, adrenal surgery, day surgery;
- Resting blood pressure ≥180/110 mmHg (2020 ISH hypertension guideline ≥ grade 3 hypertension); Or systolic blood pressure <90mmHg or mean blood pressure <65mmHg.
- Taking corticosteroids or other immunosuppressants for more than 10 days within 6 months or having a history of adrenal cortex suppression or immune system diseases;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qiang Han, 02783665480 contact
China1 site, 1 recruiting
- Recruiting
Tongji hospital
Wuhan, Hubei, 430030
Shiyong LI, 02783665480, shiyongli@hust.edu.cn
Shiyong Li
About this study
Official title: Safety of Etomidate-propofol Mixture vs. Propofol for Total Intravenous Anesthesia in Elderly Patients Undergoing Abdominal Surgery - A Randomized, Double-blind, Controlled Study
The purpose of this study is to access the safety of etomidate - propofol mixture vs propofol for total intravenous anesthesia in elderly patients undergoing abdominal surgery.
Read the detailed description
Total intravenous anesthesia (TIVA) is one of the commonly used methods for maintaining anesthesia in clinical practice. The commonly used intravenous anesthetic drugs in clinical settings include propofol and etomidate. Both have their own advantages and disadvantages in clinical application. Among them, propofol has the advantages of rapid onset, complete sedation, and quick awakening, but it is prone to injection pain, and its inhibitory effect on the circulatory system is relatively significant. The incidence of hypotension during TIVA surgery with propofol is relatively high; while hypotension during surgery significantly increases the risk of adverse cardiovascular events during the perioperative period. Etomidate is a derivative of imidazole, and it can increase the reversibility of GABAA receptor activity, inhibit synaptic transmission and impulse conduction, and exert a sedative effect. Etomidate has a rapid onset, has a minor impact on hemodynamics, and has a shorter time-quantity-related half-life compared to propofol. However, etomidate has an inhibitory effect on the adrenal cortex. Numerous studies have confirmed that etomidate, when administered as a single injection or continuous infusion, can temporarily inhibit the function of the adrenal cortex, and the adrenal cortex function of patients can recover to the preoperative baseline level within 48 hours after surgery .
Comprehensive drug administration can reduce adverse reactions caused by a single drug. Considering the complementary pharmacodynamic effects of propofol and etomidate, the combination of the two drugs is beneficial for maximizing their respective advantages and reducing adverse reactions. In vitro drug tests have confirmed that the mixture of etomidate and propofol has physical and chemical compatibility for up to 24 hours at refrigerated temperature (4℃), room temperature (25℃), and body temperature (37℃), which creates the prerequisite conditions for the mixed use of propofol and etomidate.
The etomidate-propofol mixture is currently widely used for sedation during colonoscopy, gastroscopy, and bronchoscopy, providing a complete sedative effect, and the advantages of the mixed use have been observed, such as a low incidence of hypotension after administration, low incidence of injection pain and muscle tremors, and a low incidence of nausea and vomiting after awakening . The etomidate-propofol mixture is used for TIVA in most small-sample observational studies. A prospective observational study found that the etomidate-propofol mixture has a definite clinical efficacy for elderly patients undergoing spinal surgery, with a lower incidence of hypotension, reduced cerebral oxygen metabolism, reduced postoperative neurological complications, and no increase in the incidence of drug adverse reactions . However, there is a lack of research on the safety of the etomidate-propofol mixture for other elderly surgeries during general anesthesia maintenance.
Hypotension during surgery is a common complication during general anesthesia. Severe hypotension is closely related to perioperative cardiovascular complications and stroke . Elderly patients have a higher risk during the perioperative period. Therefore, avoiding perioperative hypotension is a basic prerequisite for ensuring patient safety. Abdominal surgery is a common type of general surgery, with a large number of surgeries and relatively consistent operation times, making it convenient for case collection. Therefore, in elderly patients scheduled for elective abdominal surgery, this study explores the impact of the propofol-etomidate mixture on the incidence of hypotension during anesthesia induction and maintenance, with the aim of providing a selectable, safe, reasonable, and easily scalable medication regimen for elderly patients undergoing total intravenous anesthesia.
- Conditions
- Etomidate Combined With Propofol, Hypertension
- Being tested
- EP mixture, Propofol
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP mixtureDrug
Patients will receive etomidate - propofol mixture during induction and maintenance. Sufentanil 0.2-0.7 μg/kg，Cisatracurium 0.15 mg/kg，EP mixture（E：P=1:2） 0.1-0.25 ml/kg for induction, EP mixture 0.4~ 1.2 ml/kg/h and remifentanil 0.05μg/kg/min ~0.3 μg/kg/min for maintenance.
PropofolDrug
Patients will receive propofol during induction and maintenance.Sufentanil 0.2-0.7 μg/kg，Cisatracurium 0.15 mg/kg，propofol 0.1-0.25 ml/kg for induction, propofol 0.4~ 1.2 ml/kg/h and remifentanil 0.05μg/kg/min ~0.3 μg/kg/min for maintenance.
| Study group | Role | What they receive |
|---|---|---|
| EP group | Experimental | Patients in this group will receive etomidate- propofol mixture during induction and maintenance. Receives: Drug: EP mixture |
| P group | Active comparator | Patients in this group will receive propofol during induction and maintenance. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and duration of hypotension during anesthesia
Blood pressure fluctuations greater than 10% relative to baseline values
Measured: day 1 (The time from the start of anesthesia induction to extubation)
Secondary outcomes (5)
Success rate of sedation
① Successful induction of anesthesia, MOAA/S score to 0 or BIS<60 within 3 minutes after the end of administration; ② During the maintenance of anesthesia, there was no single BIS>60 for more than 5 minutes or the cumulative BIS>60 for more than 20% of the anesthesia time, no anticipated limb movement, and no anesthesia rescue measures during the maintenance period
Measured: day 1 (The time from the start of anesthesia induction to extubation)
Recovery time
Time from drug withdrawal to extubation
Measured: Day 1 (Time from drug withdrawal to extubation)
The type and dosage of vasoactive drugs used during operation
The type and dosage of vasoactive drugs used during operation
Measured: day 1 (The time from the start of anesthesia induction to extubation)
The incidence of postoperative nausea and vomiting
The severity of postoperative nausea and vomiting is evaluated using a Numerical Rating Scale（NRS）.Patients select a number to indicate nausea/vomiting severity:0 for none,1 -3 for mild,4-6 for moderate, and 7-10 for severe.
Measured: within 72 hours after surgery
The incidence of in-hospital complications after surgery
Complications in the cardiovascular, respiratory, renal and other systems that occurred in the hospital Complications in the cardiovascular, respiratory, renal and other systems that occurred in the hospital after the surgery
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Feb 2025
- Primary completion30 May 2026 (estimated)
- Study completion5 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Etomidate Combined With PropofolStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyong Li, Tongji Hospital
- Investigators
- Shiyong Li, Principal investigator, Department of Anesthesiology of Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019246
- Sponsor's protocol ID
- SEPTE
- Status last verified
- Jun 2025
- First submitted
- 16 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Etomidate-propofol Mixture vs. Propofol for Total Intravenous Anesthesia in Elderly Patients Undergoing Abdominal Surgery - A Randomized, Double-blind, Controlled Study
- ClinicalTrials.gov ID
- NCT07019246
- Acronym / sponsor ID
- SEPTE
- Conditions
- Etomidate Combined With Propofol, Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 5 Jun 2026 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to access the safety of etomidate - propofol mixture vs propofol for total intravenous anesthesia in elderly patients undergoing abdominal surgery.
Detailed description
Total intravenous anesthesia (TIVA) is one of the commonly used methods for maintaining anesthesia in clinical practice. The commonly used intravenous anesthetic drugs in clinical settings include propofol and etomidate. Both have their own advantages and disadvantages in clinical application. Among them, propofol has the advantages of rapid onset, complete sedation, and quick awakening, but it is prone to injection pain, and its inhibitory effect on the circulatory system is relatively significant. The incidence of hypotension during TIVA surgery with propofol is relatively high; while hypotension during surgery significantly increases the risk of adverse cardiovascular events during the perioperative period. Etomidate is a derivative of imidazole, and it can increase the reversibility of GABAA receptor activity, inhibit synaptic transmission and impulse conduction, and exert a sedative effect. Etomidate has a rapid onset, has a minor impact on hemodynamics, and has a shorter time-quantity-related half-life compared to propofol. However, etomidate has an inhibitory effect on the adrenal cortex. Numerous studies have confirmed that etomidate, when administered as a single injection or continuous infusion, can temporarily inhibit the function of the adrenal cortex, and the adrenal cortex function of patients can recover to the preoperative baseline level within 48 hours after surgery .
Comprehensive drug administration can reduce adverse reactions caused by a single drug. Considering the complementary pharmacodynamic effects of propofol and etomidate, the combination of the two drugs is beneficial for maximizing their respective advantages and reducing adverse reactions. In vitro drug tests have confirmed that the mixture of etomidate and propofol has physical and chemical compatibility for up to 24 hours at refrigerated temperature (4℃), room temperature (25℃), and body temperature (37℃), which creates the prerequisite conditions for the mixed use of propofol and etomidate.
The etomidate-propofol mixture is currently widely used for sedation during colonoscopy, gastroscopy, and bronchoscopy, providing a complete sedative effect, and the advantages of the mixed use have been observed, such as a low incidence of hypotension after administration, low incidence of injection pain and muscle tremors, and a low incidence of nausea and vomiting after awakening . The etomidate-propofol mixture is used for TIVA in most small-sample observational studies. A prospective observational study found that the etomidate-propofol mixture has a definite clinical efficacy for elderly patients undergoing spinal surgery, with a lower incidence of hypotension, reduced cerebral oxygen metabolism, reduced postoperative neurological complications, and no increase in the incidence of drug adverse reactions . However, there is a lack of research on the safety of the etomidate-propofol mixture for other elderly surgeries during general anesthesia maintenance.
Hypotension during surgery is a common complication during general anesthesia. Severe hypotension is closely related to perioperative cardiovascular complications and stroke . Elderly patients have a higher risk during the perioperative period. Therefore, avoiding perioperative hypotension is a basic prerequisite for ensuring patient safety. Abdominal surgery is a common type of general surgery, with a large number of surgeries and relatively consistent operation times, making it convenient for case collection. Therefore, in elderly patients scheduled for elective abdominal surgery, this study explores the impact of the propofol-etomidate mixture on the incidence of hypotension during anesthesia induction and maintenance, with the aim of providing a selectable, safe, reasonable, and easily scalable medication regimen for elderly patients undergoing total intravenous anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EP group | Experimental | Drug: EP mixturePatients in this group will receive etomidate- propofol mixture during induction and maintenance. |
| P group | Active comparator | Drug: PropofolPatients in this group will receive propofol during induction and maintenance. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- ASA Ⅰ~Ⅲ;
- BMI was 18-28 kg/m2;
- For elective abdominal surgery under intravenous general anesthesia;
- The expected duration of anesthesia was 1 to 4 hours.
Key exclusion criteria (9 listed)
- Septic shock and multiple organ failure diagnosed within 14 days;
- Hyperkalemia (serum potassium >5.5mmol/L) within 48 hours;
- Stroke or transient ischemic attack within 3 months;
- Patients with unstable angina pectoris or myocardial infarction within 3 months; Arrhythmia requiring treatment was not treated or treatment did not meet expectations;
- Patients with preoperative diagnosed diabetes mellitus and uncontrolled blood glucose; Diabetic complications were diagnosed before surgery, including diabetic ketoacidosis, hyperosmolar coma, diabetes-related infection, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EP mixturePatients will receive etomidate - propofol mixture during induction and maintenance. Sufentanil 0.2-0.7 μg/kg，Cisatracurium 0.15 mg/kg，EP mixture（E：P=1:2） 0.1-0.25 ml/kg for induction, EP mixture 0.4~ 1.2 ml/kg/h and remifentanil 0.05μg/kg/min ~0.3 μg/kg/min for maintenance. | Drug | EP group |
| PropofolPatients will receive propofol during induction and maintenance.Sufentanil 0.2-0.7 μg/kg，Cisatracurium 0.15 mg/kg，propofol 0.1-0.25 ml/kg for induction, propofol 0.4~ 1.2 ml/kg/h and remifentanil 0.05μg/kg/min ~0.3 μg/kg/min for maintenance. | Drug | P group |
Primary outcome
Incidence and duration of hypotension during anesthesia
Time frame: day 1 (The time from the start of anesthesia induction to extubation)
Blood pressure fluctuations greater than 10% relative to baseline values
5 secondary outcomes
Success rate of sedation
Time frame: day 1 (The time from the start of anesthesia induction to extubation)
Recovery time
Time frame: Day 1 (Time from drug withdrawal to extubation)
The type and dosage of vasoactive drugs used during operation
Time frame: day 1 (The time from the start of anesthesia induction to extubation)
The incidence of postoperative nausea and vomiting
Time frame: within 72 hours after surgery
The incidence of in-hospital complications after surgery
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Etomidate Combined With Propofol
Not yet recruiting
Etomidate Combined With Propofol Versus Propofol for Sedation in High-Altitude Patients During Gastroscopy: a Randomized Multicenter Clinical Trial
Gastrointestinal Endoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qiang Han, 02783665480 contact
Shiyong Li principal investigator
Department of Anesthesiology of Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EP mixture and Propofol in people with Etomidate Combined With Propofol and Hypertension, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiyong Li (02783665480, shiyongli@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and duration of hypotension during anesthesia (time frame: day 1 (The time from the start of anesthesia induction to extubation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.