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临床试验/CTRI/2024/11/077401
CTRI/2024/11/077401尚未招募不适用

Comparative Study Of Recovery Characteristics Using Intraoperative Dexmedetomidine With Remifentanil In Patients Undergoing Elective Laparoscopic Cholecystectomy

Teerthanker mahaveer medical college and research centre,1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年12月15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
80
试验地点
1
主要终点
To compare recovery characteristics like Richmond Agitation sedation scale(RASS)

研究概览

简要总结

After getting approval from college research committee[CRC] AND Institutional ethical committee[IEC],those patients meeting the inclusions criteria will be enrolled

Randomization will be done by computer generated random random table number and 80 patients will be assigned into two groups, Group DM and Group RF, 40 patients in each group.

Group DM : Dexemedetomidine loading dose 1mcg/kg followed by infusion dose 0.5mcg/kg/hr

Group RF : remifentanyl loading dose 1mcg/kg followed by infusion dose 0.5mcg/kg/min

Induction of anaesthesia and tracheal intubation of anaesthesia will be used as per patient characteristics and institutional protocol

Intraoperative monitoring [HR,SBP,DBP,MAP,PR,PI,SPO2] will be done as per instuitional protocol.

After Extubation, patients will be shifted post anaesthesia care unit

After they achieved Aldrete score [<9], then shift the patients PACU to ward

NRS SCORE :

MEASURED 1ST 30mins and hourly for the first 2hours and then at 4hourly interval till 24hour

All pre operative and post operative data collected will be analyzed

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 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient posted for Elective Laparoscopic Cholecystectomy.
  • Patient giving written and informed consent.
  • American Society of Anesthesiologist (ASA) physical status I-II Age group of 18-60 years old.
  • BMI 18.5kg/m2 to 24.9kg/m2.

排除标准

  • Patient history of allergy to opioids, alpha-2 receptor drugs.
  • History of alcohol and drug abuse.
  • Pregnant patients.

结局指标

主要结局

To compare recovery characteristics like Richmond Agitation sedation scale(RASS)

时间窗: 0mins,15mins,30mins,45min,1hour,2hour,4hour,8hour,12hour,16hour,20hour,24hour

To compare Pain using Numerical rating score(NRS) in both the groups.

时间窗: 0mins,15mins,30mins,45min,1hour,2hour,4hour,8hour,12hour,16hour,20hour,24hour

To compare time from post anaesthesia care unit to ward in both the groups.

时间窗: 0mins,15mins,30mins,45min,1hour,2hour,4hour,8hour,12hour,16hour,20hour,24hour

次要结局

  • To compare hemodynamics parameters in both the groups.(To compare total post operative analgesic consumption in both the groups.)

研究者

发起方
Teerthanker mahaveer medical college and research centre,
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr subidhi devadiya

teerthanker mahaveer medical college and research centre

研究点 (1)

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