Observation on Administration of Propofol at Different Titration Endpoints

NCT06685198 | Not Yet Recruiting

• 1 other identifier: 2024ZSLYEC-457
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

titration of propofol

Outcome Measures

Primary Outcomes (1)

• Incidence of a 30% decrease in MAP

  Incidence of a 30% decrease in MAP during induction with three different titration endpoints

  During the procedure of anesthesia induction

Secondary Outcomes (17)

• Proportion of cases with MAP < 65 mmHg

  During the procedure of anesthesia induction

• Anesthesia depth

  During the procedure of anesthesia induction

• Tracheal intubation conditions

  After finish intubation

• Blood glucose

  During the procedure of anesthesia induction

• Stress hormones

  During the procedure of anesthesia induction

Study Arms (3)

Group O

EXPERIMENTAL

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

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

Group T

EXPERIMENTAL

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

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

Group B

ACTIVE COMPARATOR

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

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

Interventions

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

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.

Group O

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

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.

Group T

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

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.

Group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years.
• Elective surgery with planned endotracheal intubation under general anesthesia.
• ASA classification of I or II,with heart function classified as 1 or 2.
• Body Mass Index (BMI) 18-30 kg/m².

You may not qualify if:

• Severe cardiac, pulmonary, hepatic, or renal diseases (heart function classification greater than 3 / respiratory failure / liver failure / renal failure).
• 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.
• Expected difficulty with intubation, hypoalbuminemia, hypertension, or diabetes mellitus.
• Patients with a high risk of aspiration due to a full stomach, gastrointestinal obstruction, or pregnancy.
• Patients with schizophrenia, epilepsy, Parkinson's disease, intellectual disabilities, etc.
• Alcohol abusers or those who have been using sedatives or analgesics long-term.
• Allergic to propofol or its emulsion.
• Currently participating in a clinical trial that conflicts with this study.

Sponsors & Collaborators

• SanQing Jin: lead

Study Sites (1)

the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Related Publications (19)

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Study Officials

• SanQing Jin, MD

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SanQing Jin, MD

CONTACT

0086-13719366863; jinsq@mail.sysu.edu.cn

LiHong Chen, MD

CONTACT

0086-13760779697; chenlihn@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 12, 2024
• Study Start: February 20, 2025
• Primary Completion: June 20, 2025
• Study Completion: August 20, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)