Application of the Propofol Precise Infusion Model

Completed

• Conditions: Propofol Overdose of Undetermined Intent
• Interventions: Drug: Propofol

• Registration Number: NCT05158426
• Lead Sponsor: West China Hospital

Brief Summary

Propofol is one of the most commonly used anesthetics in the world. However, the dose-response of propofol was remarkable variety. Herein, this study aims to investigate the possible association of gene polymorphism and propofol susceptibility, and to research more precise infusion model of this drug.

Detailed Description

Patients undergoing gastrointestinal endoscopy will be recruited. Anesthesia is induced with propofol via TCI at 1.5µg/ml, and increases 0.5µg/ml for every 3min until OAA/S score 0. During this period, OAA/S score will be evaluated every 1min until OAA/S score 0. At this moment, the blood concentration of propofol, the doses of propofol, the onset time and BIS are recorded, and blood sample for gene polymorphism detection were required.

Study Timeline

• Study Start: 2019-11-20
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-18
• Study First Submitted: 2021-11-18
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-14
• Last Update Submitted: 2021-12-14
• Study First Posted: 2021-12-15
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. patients who undergoing gastrointestinal endoscopy with anesthesia
2. age ≥18 years

Exclusion Criteria

1. hepatic or kidney function injured;
2. received hypnotic sedative drug regularly;
3. Pregnancy, excessive drinking, or current smoker;
4. be allergic to propofol
5. patients who with difficulty communication

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
propofol susceptibility group	Propofol	patients undergoing gastrointestinal endoscopy

Primary Outcome Measures

Name	Time	Method
gene polymorphism of propofol susceptibility	from anesthesia induction to the end of the gastrointestinal endoscopy	combination of the blood concentration of propofol (ng/ml) with the onset time(min) at OAA/S score of 0 to demonstrate propofol susceptibility, the gene polymorphism of propofol susceptibility will be detected with the blood sample of subjects.

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China