A Double-Blind, Randomized, Crossover Design Study To Compare The Rocuronium Reversal By Sugammadex To Succinylcholine For Electroconvulsive Therapy (ECT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Recovery Time of T1 to 90% Baseline
研究概览
简要总结
The investigators propose to compare the recovery of neuromuscular blockade from rocuronium reversal by sugammadex to succinylcholine in ECT.
详细描述
The proposed study is a single center, randomized, double-blind (patients, psychiatrists and outcome assessor), cross-over clinical trial comparing the recovery of neuromuscular blockade from rocuronium with reversal of sugammadex to succinylcholine in participants receiving ECT. The primary outcome will be the measurement of time when the first train-of-four (TOF) twitch (T1) returns to 90% of baseline. The secondary aims are to document the safety (adverse event rates) of rocuronium/sugammadex compared to succinylcholine in ECT patients. The exploratory aims are to establish the perioperative efficacy and efficiency of sugammadex reversal of rocuronium in ECT procedures in comparison with succinylcholine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The randomization of treatment groups will be blinded to the patients themselves, the psychiatrists and outcome assessors, except the anesthesiologists who will administer the drugs.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible and scheduled for ECT
- •Has the capacity to consent for the study
排除标准
- •Any acute major organ failure in the last 30 days
- •Any known or suspected neuromuscular disorders
- •Any history of allergic reaction or intolerance to sugammadex, rocuronium, or succinylcholine
- •Any conditions with severe renal impairment, including those requiring dialysis
- •Anyone currently taking lithium
- •Anyone currently taking hormonal contraceptives
- •Anyone taking anti-coagulants, including vitamin K antagonists, unfractionated heparin, low molecular weight heparinoids, rivaroxaban, and dabigatran
结局指标
主要结局
Recovery Time of T1 to 90% Baseline
时间窗: 30 minutes
The time of neuromuscular recovery from sugammadex 4mg/kg dose reversal rocuronium at 0.6 mg/kg compared with traditionally used succinylcholine in electroconvulsive therapy (ECT).
次要结局
- Number of Participants With Treatment or Emergent Adverse Events of the Drugs(24 hours after the procedure)