STOP trial

Phase 2

Recruiting

• Conditions: Gallbladder Diseases,Pancreatic Diseases, Digestive System Neoplasms, Inflammatory Bowel Diseases; Endoscopic therapy; D005705,D010182,D004067,D015212

• Registration Number: JPRN-jRCTs032190146
• Lead Sponsor: Kato Naoya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 269

Inclusion Criteria

We include patients undergoing invasive endoscopic procedure (ERCP,ESD,EUS-FNA,DBE) under sedation.
1)Ages 20 and older (any gender)
2)Patients with written consent after receiving sufficient explanation for this study. The consent is based on free will.
3)Percutaneous oxygen saturation(SPO2) 95% or more in room air.
4)Systolic blood pressure 90mmHg or more

Exclusion Criteria

Patients who fall under any of the following criteria, will be excluded from the study.
1)Patients who usually use opioid or benzodiazepine not for sleeping drug.
2)Patients who have been enrolled another clinical trial within 4 weeks of registry of this trial.
3)Patients who abuse drugs or is considered too terrible condition of physical, mental or circumstance for enrollment or evaluation.
4)Patients who have any cardiac disorder of the following.
a)Heart failure of NYHA class 3 or higher.
b)Coronary artery disease with symptoms. History of myocardial infarction within 24 weeks prior to enrollment.
c)Arrhythmias requiring control with antiarrhythmic drugs such as beta blocker and digoxin (CTCAE version 4.0 Grade 3 or higher).
d)Poor control hypertension.
5)Bradycardia (heart rate less than 50/min)
6)American Society of Anesthesiologists (ASA) physical status classification 4 or more
7)Patients with severe thyroid disease.
8)Pregnant or lactating woman; woman of child bearing age unless using effective contraception (In case of suspected pregnancy, pregnancy test should be conducted)
9)Possibility of allergic reaction to propofol or fentanyl.
10)Any condition that in the opinion of the investigators could impair the patient's safety or make the study difficult to comply with the protocol by participating in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified