- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05810363
The Safety of Etomidate - Propofol Mixture vs Propofol in Total Intravenous Anesthesia During Abdominal Surgery
The Safety of Etomidate - Propofol Mixture vs Propofol in Total Intravenous Anesthesia During Abdominal Surgery : a Randomized, Double-blind, Controlled, Multicenter Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Total intravenous anesthesia (TIVA) is one of the common anesthesia maintenance methods in clinic. Intravenous anesthetics commonly used in clinical practice include propofol and etomidate, both of which have their own advantages and disadvantages. Among them, propofol has the advantages of rapid onset, complete sedation and rapid recovery, but it is easy to cause injection pain. Moreover, the inhibitory effect of propofol on the circulatory system is more obvious, and the incidence of hypotension during propofol use in TIVA is higher. In contrast, intraoperative hypotension substantially increases the risk of perioperative adverse cardiovascular and cerebrovascular events. Etomidate, a derivative of imidazole, reversibly increases GABAA receptor activity and inhibits synaptic transmission and impulse transmission, resulting in sedation. Etomidate has a rapid onset of action, minimal hemodynamic effects, and a shorter dose-related half-life than propofol; however, etomidate has a suppressive effect on the adrenal cortex. Several studies have confirmed transient suppression of adrenocortical function with a single injection or continuous pump of etomidate, with recovery of preoperative baseline adrenocortical function within 48 hours after surgery.
Combined drugs can reduce the adverse reactions caused by single drugs. Considering the complementary effects of propofol and etomidate in pharmacodynamic characteristics, the combination of propofol and etomidate is beneficial to maximize their respective advantages and reduce adverse reactions.
Intraoperative hypotension is a common complication during general anesthesia, and severe hypotension is closely related to perioperative cardiovascular complications and stroke ; therefore, avoiding perioperative hypotension is the basic premise to ensure patient safety. Abdominal surgery is a common type of general surgery, with a large number of operations and relatively uniform operation time, which is easy to collect cases. Therefore, this study aims to investigate the effect of propofol-etomidate mixture used in TIVA on the incidence of hypotension during anesthesia induction and maintenance in adult patients undergoing elective abdominal surgery, in order to provide an alternative, safe, reasonable and easy to promote medication regimen for total intravenous anesthesia.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ailin Luo, Dr
- Phone Number: 02783665480
- Email: alluo@tjh.tjmu.edu.cn
Study Contact Backup
- Name: Shiyong Li, Dr
- Phone Number: 02783665480
Study Locations
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Wuhan, China
- Recruiting
- Tongji Hospital
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Contact:
- Shiyong Li, MD&phd
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Principal Investigator:
- Ailin Luo, M.D.&PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Pregnant patients;
- 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;
- 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;
- Patients who participated in other drug trials within 3 months;
- Patients with disturbance of consciousness or other mental diseases;
- Confirmed/suspected abuse or long-term use of narcotic sedatives and analgesics;
- Patients with cancer who received neoadjuvant therapy or chemotherapy before surgery;
- Allergic to the drug used in this trial and its components.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EP group
Patients in this group will receive etomidate- propofol mixture during induction and maintenance.
|
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.
Other Names:
|
Experimental: P group
Patients in this group will receive propofol during induction and maintenance.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and duration of hypotension during anesthesia
Time Frame: during anesthesia
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Systolic blood pressure ≤90 mmHg, or > 20% reduction from baseline, or mean arterial pressure <65 mmHg, from the time when anesthesia induction began to the time before the patient complied with transfer out of PACU
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during anesthesia
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success rate of sedation
Time Frame: during anesthesia
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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
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during anesthesia
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Recovery time
Time Frame: during anesthesia
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Time from drug withdrawal to extubation
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during anesthesia
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The type and dosage of vasoactive drugs used during operation
Time Frame: during anesthesia
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The type and dosage of vasoactive drugs used during operation
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during anesthesia
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The incidence of postoperative nausea and vomiting
Time Frame: 72 hours after surgery
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The incidence of postoperative nausea and vomiting
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72 hours after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ailin Luo, Dr, Department of Anesthesiology of Tongji Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SEPT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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