UNSTOP trial

JRCT ID: jRCTs032190146

Registered date:29/11/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gallbladder Diseases,Pancreatic Diseases, Digestive System Neoplasms, Inflammatory Bowel Diseases
• Date of first enrollment: 05/12/2019
• Target sample size: 269
• Study type: Interventional
• Intervention(s): Breathing monitoring with capnography or nasal pressure waveform

Outcome(s)

• Primary Outcome: Incidence 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 maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Kato Naoya