Evaluation of effect of Dexmedetomidine on Succinylcholine induced fasciculations and myalgia in patients undergoing electroconvulsive therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. Succinylcholine induced fasciculations
研究概览
简要总结
The study aims to investigate if Dexmedetomidine affects succinylcholine induced myalgia and fasciculations in psychiatric patients undergoing electroconvulsive therapy.Patients are randomly allocated into 2 groups - Group C (control) and group D(dexmedetomidine) using computer generated sequence. Patients are explained about grading of pain.
Patients in the control group are given 10 ml normal saline IV. Patients in the dexmedetomidine group are given dexmedetomidine 0.25 mcg/kg IV diluted in 10 ml normal saline.Patients are shifted to the ECT room. Monitors are attached for continually monitoring heart rate, blood pressure, oxygen saturation. An IV line is secured.
Patients in the dexmedetomidine group are given IV dexmedetomidine 0.25 mcg/kg diluted in 10 ml normal saline over 10 minutes. Patients in the control group are administered 10 ml normal saline.Patients are preoxygenated with 100% oxygen. Patients are administered Inj glycopyrrolate 0.2 mg IV. IV induction is done using Inj propofol 1 mg/kg IV and Inj succinylcholine 1.5 mg/kg IV. Fasciculations are noted and graded using Mingus scale. Patients are ventilated using bag and mask. An electrical stimulus is applied through the scalp
electrodes after ensuring complete paralysis. Bag and mask ventilation is initiated after cessation of seizure activity in electroencephalogram until the patient’s spontaneous breathing is sufficient. Myalgia is measured 30 mins after the procedure using self reported myalgia scores developed by Harvey et al. Inj Paracetamol 1 g IV is given to patients with pain score of 2 or more (scale
by Harvey et al).
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
- 18.00 Day(s) 至 65.00 Day(s)（—）
- 性别
- All
入选标准
- •Patients of the American Society of Anesthesiologists (ASA) physical status I/II aged 18–65 years undergoing ECT at VMMC and Safdarjung Hospital.
排除标准
- •Blind or deaf patients Allergic to dexmedetomidine Second- or third-degree heart block or persistent bradycardia Taking beta blockers or other antiarrhythmic drugs Pregnant or lactating women.
结局指标
主要结局
1. Succinylcholine induced fasciculations
时间窗: 1. Succinylcholine induced fasciculations | 2. Succinylcholine induced myalgia 30 minutes after the procedure
2. Succinylcholine induced myalgia 30 minutes after the procedure
时间窗: 1. Succinylcholine induced fasciculations | 2. Succinylcholine induced myalgia 30 minutes after the procedure
次要结局
- Hemodynamic parameters(- Heart rate)
研究者
Vidya V
VMMC and Safdarjung Hospital