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Clinical Trials in China / NCT06685198
Starting soon Not applicable

Observation on Administration of Propofol at Different Titration Endpoints

NCT06685198 · tracked via the Priya Life Science China tracker
Sponsor
SanQing Jin
Phase
Not applicable
Started
2025-02-20
Last updated
2024-12-04

Condition(s) studied

Anesthesia, GeneralHemodynamics

Investigational drug(s) / intervention(s)

Titrated administration of propofol to an OAA/S score of 1 as the endpointTitrated administration of propofol to an OAA/S score of 2 as the endpointTitrated administration of propofol to a BIS value ≤ 60 as the endpoint

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.

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.

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-60 years. 2. Elective surgery with planned endotracheal intubation under general anesthesia. 3. ASA classification of I or II,with heart function classified as 1 or 2. 4. Body Mass Index (BMI) 18-30 kg/m². Exclusion Criteria: 1. Severe cardiac, pulmonary, hepatic, or renal diseases (heart function classification greater than 3 / respiratory failure / liver failure / renal failure). 2. Malignant arrhythmias: atrial flutter, atrial fibrillation, atrioventricular block, frequent ventricular premature beats, multifocal ventricular premature beats, ventricular premature beats R on T, ventricular flutter, and ventricular fibrillation. 3. Expected difficulty with intubation, hypoalbuminemia, hypertension, or diabetes mellitus. 4. Patients with a high risk of aspiration due to a full stomach, gastrointestinal obstruction, or pregnancy. 5. Patients with schizophrenia, epilepsy, Parkinson's disease, intellectual disabilities, etc. 6. Alcohol abusers or those who have been using sedatives or analgesics long-term. 7. Allergic to propofol or its emulsion. 8. Currently participating in a clinical trial that conflicts with this study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
the Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06685198 on ClinicalTrials.gov ↗ ← All trials in China