[Translation] A randomized, single-blind, etomidate parallel-controlled, multicenter phase II clinical study evaluating the efficacy and safety of methetomidate hydrochloride for injection in the induction of general anesthesia in patients undergoing elective surgery
Ⅱa 期: 主要研究目的 确定联合用药下的 ET-26 在择期手术受试者全身麻醉诱导时的临床推荐剂量。 次要研究目的 评价 ET-26 在择期手术受试者全身麻醉诱导中的安全性(包括循环稳定性、 呼吸抑制率、不良事件等)和有效性(包括意识消失的过程情况等)。 探索性目的 评估 ET-26/依托咪酯、依托咪酯酸的药代动力学(PK)特征,评估 ET-26、依托咪酯对肾上腺皮质功能的影响。
Ⅱb 期: 主要研究目的 评价临床推荐剂量的 ET-26 与临床推荐剂量的依托咪酯注射液(简称依托 咪酯)相比,在择期手术患者全身麻醉诱导中的有效性。 次要研究目的 评价 ET-26 与依托咪酯相比在择期手术患者全身麻醉诱导中的安全性(包 括循环稳定性、呼吸抑制率、肌阵挛、不良事件等)及对血清皮质醇的影响。 探索性目的 评估 ET-26/依托咪酯、依托咪酯酸的药代动力学(PK)特征。
[Translation] Phase IIa: Primary study objective To determine the clinically recommended dose of ET-26 in combination therapy for induction of general anesthesia in subjects undergoing elective surgery. Secondary research objectives To evaluate the safety (including circulatory stability, respiratory depression rate, adverse events, etc.) and efficacy (including the process of loss of consciousness, etc.) of ET-26 in the induction of general anesthesia in elective surgery subjects. Exploratory purpose To evaluate the pharmacokinetic (PK) characteristics of ET-26/etomidate and etomidate acid, and to evaluate the effect of ET-26 and etomidate on adrenal cortical function.
Phase IIb: Main study objective To evaluate the efficacy of clinically recommended doses of ET-26 compared with clinically recommended doses of etomidate injection (referred to as etomidate) in induction of general anesthesia in patients undergoing elective surgery. Secondary study objective To evaluate the safety of ET-26 compared with etomidate in induction of general anesthesia in patients undergoing elective surgery (including circulatory stability, respiratory depression rate, myoclonus, adverse events, etc.) and its effect on serum cortisol . Exploratory Objectives To evaluate the pharmacokinetic (PK) characteristics of ET-26/etomidate, etomidate acid.