NIPH Clinical Trials Search

JRCT ID: jRCTs032190146

Registered date:29/11/2019

UNSTOP trial

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedGallbladder Diseases,Pancreatic Diseases, Digestive System Neoplasms, Inflammatory Bowel Diseases
Date of first enrollment05/12/2019
Target sample size269
Countries of recruitment
Study typeInterventional
Intervention(s)Breathing monitoring with capnography or nasal pressure waveform


Primary OutcomeIncidence of hypoxemia (percutaneous oxygen saturation less than 90%)
Secondary Outcome(Secondary outcomes of efficacy) Frequency of apnea(cessation of breathing for 20 seconds or longer). Satisfaction of procedure assessed by visual analog scale. Cooperativeness in procedure assessed by visual analog scale. Safety(checking other vital signs.) Secondary outcomes of safety Frequency of adverse events

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteriaWe 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
Exclude criteriaPatients 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.

Related Information


Public contact
Name Rintaro Mikata
Address 1-8-1, Inohana, Chuo-ku, Chiba city, Chiba Chiba Japan 260-8677
Telephone +81-43-222-7171
Affiliation Chiba University Hospital
Scientific contact
Name Naoya Kato
Address 1-8-1, Inohana, Chuo-ku, Chiba city, Chiba Chiba Japan 260-8677
Telephone +81-43-222-7171
Affiliation Chiba University Hospital