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

May 14, 2025 updated by: Akira Horiuchi, Showa Inan General Hospital

Propofol Sedation of More Than 200 mg Enables Patients to Drive Home After Outpatient Colonoscopy Including Colorectal Polypectomy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Nagano
      • Komagane, Nagano, Japan, 399-4191
        • Showa Inan General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Traffic accidents
Time Frame: 1 day
Number of traffic accidents
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 1 day
Patient satisfaction (bad, 0-good 100%) is asked.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Showa Inan General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2022

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

January 15, 2022

First Submitted That Met QC Criteria

January 15, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

May 18, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS>200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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