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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05213208
• Other study ID #: PS>200
• Status: Recruiting
• Start date: January 16, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Showa Inan General Hospital
• Contact: Akira Horiuchi, MD
• Phone: 09021684311
• Email: horiuchi.akira[@]sihp.jp
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Safety Issues

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Japan	Showa Inan General hospital	Komagane	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Traffic accidents	Number of traffic accidents	1 day
Secondary	Patient satisfaction	Patient satisfaction (bad, 0-good 100%) is asked.	1 day