Observation on Administration of Propofol at Different Titration Endpoints

NCT06685198 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2024-12-04

No results posted yet for this study

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.

Conditions

  • Anesthesia, General
  • Hemodynamics

Interventions

PROCEDURE

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

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.

PROCEDURE

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

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.

PROCEDURE

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

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.

Sponsors & Collaborators

  • SanQing Jin

    lead OTHER

Principal Investigators

  • SanQing Jin, MD · The Sixth Affiliated Hospital, Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-20
Primary Completion
2025-06-20
Completion
2025-08-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06685198 on ClinicalTrials.gov