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Clinical Trials/NCT05158426
NCT05158426
Completed
Not Applicable

Application of the Propofol Precise Infusion Model

West China Hospital1 site in 1 country400 target enrollmentNovember 20, 2019

Overview

Phase
Not Applicable
Intervention
Propofol
Conditions
Propofol Overdose of Undetermined Intent
Sponsor
West China Hospital
Enrollment
400
Locations
1
Primary Endpoint
gene polymorphism of propofol susceptibility
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 20, 2019
End Date
November 18, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lei Du

professor

West China Hospital

Eligibility Criteria

Inclusion Criteria

  • patients who undergoing gastrointestinal endoscopy with anesthesia
  • age ≥18 years

Exclusion Criteria

  • hepatic or kidney function injured;
  • received hypnotic sedative drug regularly;
  • Pregnancy, excessive drinking, or current smoker;
  • be allergic to propofol
  • patients who with difficulty communication

Arms & Interventions

propofol susceptibility group

patients undergoing gastrointestinal endoscopy

Intervention: Propofol

Outcomes

Primary Outcomes

gene polymorphism of propofol susceptibility

Time Frame: 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.

Study Sites (1)

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