CI

At a glance

ClinicalIndex Comparison Record
N/ANot Yet Recruiting· 258 target
Drug / intervention
Titrated administration of propofol to an OAA/S score of 1 as the endpoint +2 moreprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06685198
NCT06685198N/ANot Yet Recruiting

The Impact of Different Titration Endpoints of Propofol on Hemodynamics and Stress During the Induction Phase of General Anesthesia

SanQing Jin·interventional·Posted Nov 12, 2024·Updated Dec 4, 2024

In Brief

A clinical study evaluating Titrated administration of propofol to an OAA/S score of 1 as the endpoint, Titrated administration of propofol to an OAA/S score of 2 as the endpoint, and 1 other intervention for Anesthesia, General and Hemodynamics. Not yet recruiting, targeting 258 participants across 1 site.

Detailed Summary

Propofol has a rapid onset and short duration of action, making it widely used for induction of general anesthesia. However, its prominent drawback is circulatory depression. Our research team previously proposed an individualized dosing method for the titration of propofol. We then compared the effects of different titration rates of propofol on hemodynamics and stress during general anesthesia induction. It was found that the incidence of hypotension during the induction period was lower in the 0.5 mg/kg/min group, with lower stress levels and faster postoperative recovery. However, this group still had a 25.3% incidence of hypotension. Therefore, we plan to further study the differences in hemodynamics, depth of anesthesia, stress response, and postoperative recovery in three groups of patients induced with a constant infusion rate of propofol at 0.5 mg/kg/min titrated to an OAA/S score of 1, an OAA/S score of 2, and BIS ≤ 60, combined with remifentanil 2 μg/kg. This study aims to explore the appropriate propofol titration endpoint during general anesthesia induction to maintain stable perioperative haemodynamics and achieve rapid postoperative recovery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ANot Yet RecruitingOverdue
20252026
First PostedNov 12, 2024
Enrollment StartFeb 20, 2025
Primary CompletionJun 20, 2025
Study CompletionAug 20, 2025
TodayJul 1, 2026
Enrollment to primary: 4 monthsPosted 1.6 years ago

Interventions

Titrated administration of propofol to an OAA/S score of 1 as the endpointprocedure

Propofol is titrated at a rate of 0.5 mg/kg/min to achieve an OAA/S score of 1, followed by a maintenance dose of 2-4 mg/kg/h, concurrently with remifentanil 2 ug/kg and rocuronium 0.6 mg/kg for anesthesia induction.

Titrated administration of propofol to an OAA/S score of 2 as the endpointprocedure

Propofol is titrated at a rate of 0.5 mg/kg/min to achieve an OAA/S score of 2, followed by a maintenance dose of 2-4 mg/kg/h, concurrently with remifentanil 2 ug/kg and rocuronium 0.6 mg/kg for anesthesia induction.

Titrated administration of propofol to a BIS value ≤ 60 as the endpointprocedure

Propofol is titrated at a rate of 0.5 mg/kg/min to achieve a BIS value ≤ 60, followed by a maintenance dose of 2-4 mg/kg/h, concurrently with remifentanil 2 ug/kg and rocuronium 0.6 mg/kg for anesthesia induction.