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临床试验/CTRI/2018/07/014901
CTRI/2018/07/014901尚未招募3 期

A PROSPECTIVE RANDOMIZED COMPARATIVE STUDY OF INTRAVENOUS DEXEMEDETOMIDINE VERSUS MAGNESIUM SULPHATE [MgSO4] AS AN ADJUNCT DURING ANAESTHESIA FOR LAPROSCOPIC CHOLECYSTECTOMY

SSG HOSPITAL VADODARA1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年7月25日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
It will be expected that both drugs will be effectively able to attenuate hemodynamic stress response during anaesthesia for laparoscopic cholecystectomy with CO2 pneumoperitoneum

研究概览

简要总结

70 patients of ASA status 1 and 2 ,aged between 18 to 65 years ,of either sex ,scheduled for laparoscopic cholecystectomy were randomized in 2 groups (group D and group M)in a single blind fashion ,to receive either dexmedetomidine1mcg/kg,magnesium sulphate 40mg/kg in normal saline iv respectively .Total volume of the study drug was adjusted to 20 ml and administered over 15 mins before induction .Aesthesia was induced with propofol till loss of eyelid reflex followed by inj succinylcholine 2mg/kg. Laryngoscopy  and intubation were done with appropriate size mac intosh blade and endotracheal tube .Hemodynamic parameters of patients including HR,SBP,RPP,MAP,SPO2,ETCO2,ECG were recorded at different time interval as below           1 baseline           2 before ad after infusion           3 after intubation           4 after pneumoperitoneum           5 after release of pneumoperitoneum           6 after extubation.

Post operative sedation and analgesia were assessed.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant 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

  • 1Age Group 18 -65years 2ASA status I & II 3Male / female Patients posted for laparoscopic cholecystectomy.

排除标准

  • •Anticipated difficult airway and obesity •Patient having allergy to study drug •Patient with systemic diseases like severe hypertension, cardiovascular, respiratory, neurological, psychological, hepatic, renal disease (diagnosed by clinical judgments and investigations) and on medication of above mentioned diseases •Patients with heart rate <60 beats/mi •Pregnant or lactating females •Patients who refuse to give consent.

结局指标

主要结局

It will be expected that both drugs will be effectively able to attenuate hemodynamic stress response during anaesthesia for laparoscopic cholecystectomy with CO2 pneumoperitoneum

时间窗: 1.Baseline | 2.Before and after infusion | 3.Before and after intubation | 4.Before and after Pneumoperitoneum | 5.After release of Pneumoperitoneum | 6.After Extubation

次要结局

  • 1Amount of induction agent used(2Post-operative sedation –Ramsay sedation score)

研究者

发起方
SSG HOSPITAL VADODARA
申办方类型
Government medical college

研究点 (1)

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