A Randomised study to compare Suggamadex Vs Neostigmine in Reversal of Vecuronium based Neuromuscular Block in Geriatric patients.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- recovery time from administration of reversal to reach train of four ratio greater than or equal to 0.9
研究概览
简要总结
This is a prospective, double-blind , randomised control study to be conducted in various Operation Theatres under the Department of Anaesthesiology and Critical Care,Gauhati Medical college and hospital, Guwahati. The study will be carried out on Geriatric patients ( age greater than 60 years ) of both sexes posted for elective surgeries.The aim of this study is to compare the Neuromuscular block recovery by using Suggamadex vs Neostigmine for Vecuronium Neuromuscular block in Geriatric patients undergoing General Anaesthesia. The Secondary objective of this study is to compare the time to extubation, time of shifting the patient from Operating Room and hemodynamic changes after administration of reversal agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •INCLUSION CRITERIA 1)Patient with age greater than 60 years irrespective of sex of the patient.
- •Patient who are undergoing Elective Surgery in various OT under general anesthesia 3)Patients with ASA grade 1 and 2 4)Patients who have given written and informed consent.
排除标准
- •Patient refusal to give consent 2)Patient with any known or suspected neuromuscular disease 3) Anticipated difficult intubation 4)History suggestive of sensitivity to drugs used in the study 5)Personal or Family history of Malignant hyperthermia 6)Patient with known case of Chronic Kidney Disease 7)Patient with known case of Chronic Liver Disease.
结局指标
主要结局
recovery time from administration of reversal to reach train of four ratio greater than or equal to 0.9
时间窗: 1 hr
次要结局
- Time to tracheal extubation(1.5 hrs)
- Time of shifting the patient from Operating Room to Post Operative Care Unit(2 hrs)
- Hemodynamic change(( Heart Rate , Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure , ECG rhythm ) after administration of the reversal)
研究者
Dr Kalieswaran Murugan
Department of Anaesthesia, Gauhati medical college and hospital,