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临床试验/CTRI/2021/11/038123
CTRI/2021/11/038123尚未招募不适用

Comparative study of hemodynamic changes with dexmedetomidine versus magnesium sulphate as adjuncts during anaesthesia in laparoscopic surgeries – a double blinded randomised study

Chettinad Hospital And Research Institute1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年11月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
hemodynamic response of two drugs during intubation and CO2 insuffulation

研究概览

简要总结

•      All patients undergoing laparoscopic surgeries will undergopre-anaesthetic assessment and informed and written consent will be taken.

•      The drugs to be given - group D: dexmedetomidine loading 1 mcg/kg in 100mL normal saline over 15 min; and Group M: magnesium sulfate 50mg/kg in 100 mLover 15 min, prior to intubation.

•      Baseline data systolic blood pressure (SBP), diastolic blood pressure(DBP), mean arterial blood pressure (MAP), and heart rate (HR) werenoninvasively monitored

•      SBP,DBP, MAP and HR to be monitored at every 10 min intervals throughout thesurgery.

Following extubation, patientswere maintained on supplemental O2 and transferred to recovery room.

•      Intubationresponse : immediately after intubation (T0), 1 min after intubation (T1),3mins after inubation (T3), 5mins after intubation (T5)

•      CO2 insufflation :1mins after insufflation (C1), 3mins afterinsufflation(C3), 5mins after insufflation (C5)

•      Extubation response : immediately after extubation (E0), 1min afterextubation (E1), 5mins after extubation (E5)

•      The degree of sedation was assessed at the end of surgery after thepatient is received in the recovery room using Brussels sedation scale

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • asa grade 1 and 2 elective and emergency laparoscopic surgeries.

排除标准

  • morbid obesity pregnant woman renal or hepatic dysfunction cardiovascular insufficiency.

结局指标

主要结局

hemodynamic response of two drugs during intubation and CO2 insuffulation

时间窗: At baseline. | Intubation response : Immediately after intubation(T0) | 1 mintue after intubation (T1) | 3 mintues after intubation (T3) | 5 minutes after intubation (T5) | Before insuffulation | 1 minute after CO2 insuffulation (C1) | 3 minutes after CO2 insuffulation (C3) | 5 minutes after CO2 insuffulation (C5) | Every 10 minute intraoperative monitoring

次要结局

  • hemodynamic response of two drugs during extubation and postoperative sedation score of patient(5 minutes post extubation)

研究者

发起方
Chettinad Hospital And Research Institute
申办方类型
Private medical college

研究点 (1)

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