A Randomized, Single-Blind, Investigator Initiative Trial Study of Remimazolam Versus Midazolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy

Samsung Medical Center0 个研究点目标入组 132 人开始时间: 待定最近更新: 2023年2月8日

适应症

试验速览

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•1) Adult men and women between the ages of 18 and 60 at the time of obtaining consent
•2) Those who are scheduled for a sedative upper endoscopy for diagnostic purposes
•3) Those who are expected to perform endoscopy in less than 15 minutes
•4) American Society of Anesthesiologists (ASA) Score = 2
•5) Those with a BMI of 18.5 kg/m2 or more and less than 30 kg/m2

•1) A person who is suspected of having a pathological condition in the gastrointestinal tract and is likely to need a therapeutic endoscopy
•2) Those who have a history of breathing problems during sedation (e.g. chronic obstructive pulmonary disease, respiratory disorders due to cerebrovascular disease and musculoskeletal muscle disease, those with tracheal cannulas, etc.)
•3) Those who are judged to have difficulty maintaining the airway (Mallampati Score = 3)
•4) Subjects with a sitting systolic blood pressure of 160 mmHg or more or 90 mmHg or less before randomization
•5) Patients with uncontrolled hypertension
•6) Patients with acute narrow-angle glaucoma
•7) Patients with severe hepatic impairment or chronic kidney disease
•8) Those with a history of drug abuse or alcohol abuse in the past 1 year
•9) Those with hypersensitivity to other benzodiazepine drugs and components of remimazolam (eg, dextran, etc.)
•10) Those with hypersensitivity to the components of midazolam
•11) Patients with sleep apnea syndrome
•12) Those with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
•13) Pregnant women, lactating women, or those who have a positive pregnancy test during screening

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