Safety of Propofol Sedation ( > 200 mg) for Colonoscopy.

NCT ID: NCT05213208

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-16

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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The hospital policy of routine discharge to normal activity 1 hour after propofol mono-sedation for EGD or colonoscopy was approved by the ethics committee of Showa Inan General Hospital in January, 2004 (http://www.sihp.jp). The investigator' s subsequent experience verified the safety of this discharge policy which was reconfirmed in March 2014. Based on these studies, the upper limit of 200 mg was established for those allowed early discharge and driving to home.

This study examines that the use of \>200 mg of propofol sedation enables patients to drive home safely 90-120 minutes after outpatient colonoscopy.

Conditions

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Safety Issues

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Propofol

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Showa Inan General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Akira Horiuchi

Chief of Digestive Disease Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Showa Inan General hospital

Komagane, Nagano, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 41071172 (View on PubMed)

Other Identifiers

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PS>200

Identifier Type: -

Identifier Source: org_study_id

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