Application of the Propofol Precise Infusion Model

Propofol Overdose of Undetermined Intent Clinical Trial

Official title:

Application of the Propofol Precise Infusion Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05158426
• Other study ID #: WestChinaH-2018-1
• Status: Completed
• Start date: November 20, 2019
• Est. completion date: November 18, 2021

Study information

• Verified date: December 2021
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 18, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Propofol Overdose of Undetermined Intent

Intervention

Drug:
• Propofol
anesthesia induction is initiated with intravenous infusion propofol at 1.5µg/ml, and increased 0.5µg/ml every 3min until OAA/S score 0.

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gene polymorphism of propofol susceptibility	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.	from anesthesia induction to the end of the gastrointestinal endoscopy