NCT05213208

Brief Summary

This study examines that the use of \>200 mg of propofol sedation enables patients to drive home safely after outpatient colonoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

January 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

January 15, 2022

Last Update Submit

May 14, 2025

Conditions

Keywords

drivingpropofol sedationcolonoscopy

Outcome Measures

Primary Outcomes (1)

  • Traffic accidents

    Number of traffic accidents

    1 day

Secondary Outcomes (1)

  • Patient satisfaction

    1 day

Interventions

Using \> 200 mg of propofol sedation colonoscopy is performed. 90-120 minutes after colonoscopy subjects go home. Within 1 week patients will be asked about their condition and satisfaction for colonoscopy.

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

healthy subjects who drive home after colonoscopy using propofol sedation (\>200 mg)

You may qualify if:

  • subjects who drive home by theirselves after colonoscopy using propofol sedation (\>200 mg)

You may not qualify if:

  • Subjects who received emergency procedures
  • less than 20 years old pregnant American Society of Anesthesiologists (ASA) class III or IV, overweight (body weight \>100 kg) allergic to the drugs used or its components (soybeans or eggs).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Showa Inan General hospital

Komagane, Nagano, 399-4191, Japan

Location

Related Publications (1)

  • Horiuchi I, Horiuchi K, Kitahara H, Horiuchi A. Does >200 mg of Propofol Sedation Allow Healthy Individuals to Undergo a Colonoscopy and Drive Themselves Home? J Clin Gastroenterol. 2025 Sep 30. doi: 10.1097/MCG.0000000000002252. Online ahead of print.

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Digestive Disease Center

Study Record Dates

First Submitted

January 15, 2022

First Posted

January 28, 2022

Study Start

January 16, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 18, 2025

Record last verified: 2025-05

Locations