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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 468 (actual)
• Sponsor: Ailin Luo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Etomidate
• Hypotension

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2023-06-16
• Primary completion: 2024-06-17
• Completion: 2024-10-30
• First posted: 2023-04-12
• Last updated: 2025-06-29

Locations

1 site across 1 country: China