Safety IssuesNCT05213208
Safety of Propofol Sedation ( > 200 mg) for Colonoscopy.
An observational study of Safety Issues, run by Showa Inan General Hospital at 1 site in Japan.
Trial summary
This study examines that the use of >200 mg of propofol sedation enables patients to drive home safely after outpatient colonoscopy. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Safety Issues
- What is being tested?
- Propofol
- How many people
- 300 participants
- Where
- 1 siteJapan
- Study dates
- 16 Jan 2022to 31 Dec 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: healthy subjects who drive home after colonoscopy using propofol sedation (>200 mg)
Who may be able to join
- subjects who drive home by theirselves after colonoscopy using propofol sedation (>200 mg)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Safety Issues
- Being tested
- Propofol
- Keywords
- driving, propofol sedation, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Traffic accidents
Number of traffic accidents
Measured: 1 day
Secondary outcomes (1)
Patient satisfaction
Patient satisfaction (bad, 0-good 100%) is asked.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start16 Jan 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Showa Inan General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akira Horiuchi, Showa Inan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213208
- Sponsor's protocol ID
- PS>200
- Status last verified
- May 2025
- First submitted
- 15 Jan 2022
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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. 2026 May-Jun 01;60(5):449-453. doi: 10.1097/MCG.0000000000002252. Epub 2025 Sep 30.
PubMed 41071172
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol Sedation of More Than 200 mg Enables Patients to Drive Home After Outpatient Colonoscopy Including Colorectal Polypectomy
- ClinicalTrials.gov ID
- NCT05213208
- Acronym / sponsor ID
- PS>200
- Conditions
- Safety Issues
- Keywords
- driving, propofol sedation, colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Showa Inan General HospitalUniversity, hospital or other
- Study start
- 16 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines that the use of >200 mg of propofol sedation enables patients to drive home safely after outpatient colonoscopy.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- healthy subjects who drive home after colonoscopy using propofol sedation (>200 mg)
Key inclusion criteria (1 listed)
- subjects who drive home by theirselves after colonoscopy using propofol sedation (>200 mg)
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolUsing > 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. | Drug | – |
Primary outcome
Traffic accidents
Time frame: 1 day
Number of traffic accidents
1 secondary outcome
Patient satisfaction
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Derived from this study: PubMed 41071172Horiuchi 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. 2026 May-Jun 01;60(5):449-453. doi: 10.1097/MCG.0000000000002252. Epub 2025 Sep 30.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety Issues, run by Showa Inan General Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Traffic accidents (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05213208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.