A Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase 3 Confirmatory Study to Assess Efficacy and Safety of the Moderate Sedation of ICI35,868 With and Without EES0000645/A on Gastrointestinal Endoscopy

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2013
INTERVENTION: 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. CONDITION: Subjects who undergo gastrointestinal diagnostic endoscopy or gastrointestinal endoscopic polypectomy INCLUSION 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.).
Epistemonikos ID: 3d4cc248e0d57760973bacf0bab1225ef40d4e82
First added on: Aug 26, 2024