Clinical trial NCT03669484: Comparative Clinical Study of Efficacy and Safety of Remimazolam and Propofol in Patients Undergoing Elective Surgery Under General Anaesthesia
Official title: International Multicenter Single Blind Randomized Clinical Study to Compare Efficacy and Safety of Remimazolam and Propofol in Patients Undergoing Elective Surgical Procedures Under General Anesthesia
Conditions: General Anaesthesia
Summary: The purpose of this study was to perform comparative evaluation of clinical efficacy and safety of Remimazolam and Propofol for induction and maintenance of general anesthesia in patients undergoing elective surgery under general anaesthesia.
Interventions:
description: Lyophilisate for preparation of solution for intravenous administration, 50 mg. Required to prepare a 50 ml syringe with the infusion solution at a concentration of 1 mg/ml (in accordance with guidance given in protocol)
name: Remimazolam
type: Drug
description: Emulsion for infusion, 10 mg/mL in 20-mL glass vials
name: Propofol
other_name: Diprivan®
type: Drug
description: Solution for intravenous administration, 50 mg/mL. Used for anesthesia induction (at a dose of 2 mg/kg) and, if necessary, anesthesia maintenance (the dose was selected individually)
name: Fentanyl
type: Drug
description: Solution for intravenous administration, 10 mg/mL. Used for anesthesia induction (at a dose of 0.6-0.9 mg/kg) and, if necessary, anesthesia maintenance (the dose was selected individually)
name: Rocuronium bromide
type: Drug
Study arms:
design_group_description: The induction of anesthesia: intravenous infusion of 6 mg/kg/h until registration of loss of consciousness.<br/>Maintenance of anesthesia: Remimazolam intravenous infusion initiated at a dose of 1 mg/kg/h; the dose level was adjusted accordingly based on a systemic patient monitoring until the end of operation to 2 mg/kg/h maximum; In case of loss of consciousness was not registered in 2.5 minutes of continuous intravenous infusion: drug administration was terminated. If loss of consciousness was not registered during 30 seconds, other sedative drugs were used for induction and maintenance of anesthesia.<br/>In case of signs of awakening (fluctuation of blood pressure/heart rate, lacrimation, sweating, etc.) were observed: intravenous bolus infusion (maximum level of 12 mg/kg/h for 1 minute). If signs of awakening remained remimazolam administration was discontinued and other sedatives were used.
design_group_title: Remimazolam
design_group_type: Experimental
design_group_description: The induction of anesthesia: intravenous infusion of 1.5-2.5 mg/kg for about 1 minute.<br/>Maintenance of anesthesia: intravenous infusion for a total dose of 4-12 mg/kg/h; the dose level was adjusted accordingly based on a systemic patient monitoring until the end of operation.<br/>In case of loss of consciousness was not registered other sedative drugs were used for induction and maintenance of anesthesia.<br/>In case of signs of awakening (fluctuation of blood pressure/heart rate, lacrimation, sweating, etc.) were observed and propofol dose adjustment had not resulted in the desired effect and signs of awakening were saved: the use of propofol was discontinued and other sedatives were used.
design_group_title: Propofol
design_group_type: Active Comparator
Sponsor: R-Pharm JSC
Collaborators: Synergy Research Group, Inc.
Drug name mappings:
name: 枸橼酸芬太尼
lang: CN
name: Fentanyl Citrate
lang: EN
name: フェンタニルクエン酸塩
lang: JP
name: 甲苯磺酸瑞马唑仑
lang: CN
name: Remimazolam Tosylate
lang: EN
name: 罗库溴铵
lang: CN
name: Rocuronium Bromide
lang: EN
name: ロクロニウム臭化物
lang: JP