CTRI/2013/11/004173进行中（未招募）3 期
Prospective, observer blind, randomized, parallel group, comparative, 2-arm study to evaluate safety and efficacy of Cisatracuruim Besylate versus Atracurium Besylate for neuromuscular blockade in adult patients, undergoing diagnostic or therapeutic surgical procedures.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Efficacy parameters
研究概览
简要总结
Prospective, observer blind, randomized, parallel group, comparative, 2- arm study to evaluate safety and efficacy of cisatracurium besylate versus atracurium besylate for neuromuscular blockade in adult patients undergoing diagnostic or therapeutic surgical procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria
- •Patients of either sex in the age group between 18 to 65 years.
- •Patients scheduled for elective diagnostic / therapeutic surgical procedure to be completed within 120 minutes with an ASA status ranging from P1 to P4
- •Subjects who provide a written informed consent to abide by the study requirements.
排除标准
- •1.Patients undergoing emergency surgical procedure / surgical procedure with likely duration for completion 120 minutes.
- •2.Patients receiving medication known to interfere with neuromuscular blockers for e.g. : anti-convulsants, amino glycosides or polypeptide antibiotics, magnesium 3.Patients with anticipated difficult intubation (Mallampati score III and more) 4.Patients with diseases affecting neuromuscular transmission (myasthenia gravis or myopathies).
- •5.Subjects known or suspected to have a (family) history of malignant hyperthermia
- •Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
- •Patients treated with any other oral / parenteral opioids or benzodiazepines within 1 week prior to the study or will continue to receive these drugs as concomitant medication during the study period.
- •Patients suffering from organic neurological disorders, psychiatric illnesses and H/o drug abuse.
- •Patients with known hypersensitivity to any of the ingredients of the test / comparator formulation.
- •10.Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
- •Pregnant and lactating females.
- •Patients simultaneously participating in another clinical study.
结局指标
主要结局
Efficacy parameters
时间窗: The train of four will be recorded every 10 min for the first 2 h (period of surgery) and then at least hourly until complete spontaneous recovery (maximum period of 6 hours) as evident from recording of train-of-four without fade phenomenon.
次要结局
- Safety parameters-(The BP, pO2, respiratory rate, pulse (HR), QTc interval(ECG), will be recorded prior to anaesthesia, during anesthesia and surgery at 10 minutes interval till end of surgery, while in the post operative period will be recorded at 2 hrs, 4hrs and 6 hours.)
研究者
研究点 (5)
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