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CompletedNCT05158426Updated Dec 15, 2021

Application of the Propofol Precise Infusion Model

An observational study in Propofol Overdose of Undetermined Intent, sponsored by West China Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-12-15.

Sponsored by West China Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Propofol Overdose of Undetermined Intent

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03

In context

Drug Overdose

139 studies on the registry are indexed under Drug Overdose; 24 are open to participants now.

This study's enrollment of 400 is above the median of 175 across 38 observational studies indexed under Drug Overdose.

Browse Drug Overdose studies →

Lead sponsor

West China Hospital is the lead sponsor of 484 studies on the registry; 241 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients who will undergo gastrointestinal endoscopy with propofol

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • propofol susceptibility group

    patients undergoing gastrointestinal endoscopy

    Drug: Propofol

Interventions

  • DrugPropofol

    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

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What researchers measure

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.

    Time frame: from anesthesia induction to the end of the gastrointestinal endoscopy

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Study locations

1 site
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610041, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05158426
Lead sponsor
West China Hospital
Responsible party
Lei Du (professor, West China Hospital) — Principal investigator
First posted
Dec 15, 2021
Start date
Nov 20, 2019
Primary completion
Nov 15, 2021
Completion
Nov 18, 2021
Last update
Dec 15, 2021

Study contacts

Weimin Li
study director · West China Hospital
lin Zhang
study director · West China Hospital

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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