The Safety of Etomidate - Propofol Mixture vs Propofol in Total Intravenous Anesthesia During Abdominal Surgery

Hypotension Clinical Trial

Official title:

The Safety of Etomidate - Propofol Mixture vs Propofol in Total Intravenous Anesthesia During Abdominal Surgery : a Randomized, Double-blind, Controlled, Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05810363
• Other study ID #: SEPT
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: February 2024
• Source: Tongji Hospital
• Contact: Ailin Luo, Dr
• Phone: 02783665480
• Email: alluo[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to access the safety of etomidate - propofol mixture vs propofol in total intravenous anesthesia during abdominal surgery.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 468
• Est. completion date: August 30, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA ?~?;

• 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.

Related Conditions & MeSH terms

• Etomidate
• Hypotension

Intervention

Drug:
• Etomidate - propofol mixture
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.
• Propofol
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.

Locations

Country	Name	City	State
China	Tongji hospital	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Ailin Luo

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and duration of hypotension during anesthesia	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	during anesthesia
Secondary	Success rate of sedation	? Successful induction of anesthesia, MOAA/S score to 0 or BIS<60 within 3 minutes after the end of administration; ? 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	during anesthesia
Secondary	Recovery time	Time from drug withdrawal to extubation	during anesthesia
Secondary	The type and dosage of vasoactive drugs used during operation	The type and dosage of vasoactive drugs used during operation	during anesthesia
Secondary	The incidence of postoperative nausea and vomiting	The incidence of postoperative nausea and vomiting	72 hours after surgery