NIPH Clinical Trials Search

Driving skill after Intravenous sedation using a Virtual Environment- Endoscopy

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Patients undergoing upper gastroint estinal endoscopy with sedation.
Date of first enrollment	11/07/2025
Target sample size	40
Countries of recruitment
Study type	Interventional
Intervention(s)	Remimazolam and midazolam sedation during gastrointestinal endoscopy

Outcome(s)

Primary Outcome

Group differences in change in driving reaction time before and 1 hour after sedated endoscopy

Secondary Outcome

(1) Sedation success rate of sedation with a upper endoscopy MOAA/S score of 4 or less. (2) Total remimazolam and midazolam dose required to complete the upper endscopic procedure. (3) Time from completion of endoscopy to ability to leave(MOAA/S score is 5,Modified Aldrete score is 9 or more). (4)Trail Making Test Japanese Version (TMT-J) Part A Results Before and One Hour after sedated upper endoscopy. (5)Driving Simulator Test results before and one hour after sedated upper endoscopy (Steering Operation Speed, Operational Accuracy, Divided Attention to Multiple Tasks, Overall Evaluation)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Patients whose written consent was already obt ained with free will. 2) Japanese patients who are 18 years of age or older and have a regular driver's license at the time of consent 3) Patients scheduled to undergo upper gastroint estinal endoscopy with sedation.
Exclude criteria	1) Patients scheduled to undergo endoscopic pro cedures. 2) Patients with a history of surgery on the upper digestive tract. 3) Patients on dialysis. 4) Patients consuming more than 60 grams of alcohol per day. 5) Patients who have severe liver dysfunction. 6) Patients with III/IV class of ASA-PS. 7) Patients who can not independently walk. 8) Patients who regularly use benzodiazepines, an algesics or central nervous system depressant. 9) Patients who have acute angle-closure glaucoma. 10) Patients who have myasthenia gravis. 11) Patients who are in pregnancy or under breast feeding. 12) Patients with a history of hypersensitivity to benzodiazepines or flumazenil, and patients with conditions or symptoms for which administration of these drugs is contraindicated. 13) Patients whom the investigator determines to be inappropriate for inclusion in the study