NCT05158426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
Last Updated

December 15, 2021

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

November 18, 2021

Last Update Submit

December 14, 2021

Conditions

Propofol Overdose of Undetermined Intent

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

propofol susceptibility group

patients undergoing gastrointestinal endoscopy

Drug: Propofol

Interventions

PropofolDRUG

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

Also known as: Diprivan
propofol susceptibility group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients who will undergo gastrointestinal endoscopy with propofol

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood sample

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Weimin Li

    West China Hospital

    STUDY DIRECTOR

  • lin Zhang

    West China Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 18, 2021

First Posted

December 15, 2021

Study Start

November 20, 2019

Primary Completion

November 15, 2021

Study Completion

November 18, 2021

Last Updated

December 15, 2021

Record last verified: 2021-12

Locations

CN(1)