NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Subjects who undergo gastrointestinal diagnostic endoscopy or gastrointestinal endoscopic polypectomy
Date of first enrollment	26/11/2013
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Propofol(ICI35,868) INN of investigational material : Propofol Therapeutic category code : 111 General anesthetics Dosage and Administration for Investigational material : The investigational product is initially administered at 0.5 mg/kg for 3 minutes, then is administered at the maintenance infusion rate of 75 ug/kg/min. According to sedation level, infusion rate can be up-titrated (maximum dose rate is 120 ug/kg/min) or decreased.

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Provision of written informed consent prior to any study-related procedures/examinations 2. Aged 20 years and older 3. Subjects who are planned to undergo a non-emergent EGD or colonoscopy, including gastrointestinal endoscopic polypectomy that shall be completed within 1 hour (excluding the endoscopic submucosal dissection and ultrasonic endoscope, pernasal endoscope, etc.).
Exclude criteria	1. involvement in the planning and/or conduct of the study (applies to both sponsor's employees and/or staffs at the study site) 2. Subjects who underwent a endoscopic procedure under ICI35,868 (propofol) administration within 1 year. 3. Participation in another clinical study with an investigational product within 4 weeks prior to randomisation. 4. Baseline (Visit 1) of blood oxygen saturation (SpO2)<90% (room air) 5. ASA III, IV, V and VI ; Subject with serious disease of cardiovascular, respiratory, renal, liver, pancreatic or endocrine function.