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临床试验/CTRI/2024/10/074979
CTRI/2024/10/074979尚未招募4 期

Comparison of analgesic efficacy of dexmedetomidine for opioid-sparing anesthesia with conventional opioid-based anesthesia for elective laparoscopic cholecystectomy: a prospective randomized controlled study.

Adarsh K P1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年10月12日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
78
试验地点
1
主要终点
Total (intraoperative and postoperative) rescue Fentanyl usage for analgesia when using Dexmedetomidine infusion compared to conventional opioid based anesthesia.

研究概览

简要总结

Laparoscopic cholecystectomy is the minimally invasive gold standard procedure for the removal of gall bladder in conditions like cholelithiasis. Unfortunately, the incidence of postoperative nausea and vomiting is as high as 55.8%which delays recovery. Perioperative opioid use is considered to be one of the reasons for it. Opioid usage is also associated with itching, respiratory depression, paralytic ileus, urinary retention, constipation, dependency, and drowsiness. Opioid-sparing anaesthesia by minimizing the perioperative opioid usage may reduce the incidence of these adverse effects and enhance recovery. In this study, Dexmedetomidine is used for opioid-sparing anaesthesia. Dexmedetomidine is a highly selective pre-synaptic alpha-2  receptor agonist having sedative, anxiolytic, hypnotic, analgesic and sympatholytic properties.

Various studies have shown the analgesic efficacy of dexmedetomidine and its hemodynamic stability in varying doses and in conjunction with other opioid sparing techniques. Studies have established the effect of dexmedetomidine in reducing post-operative nausea and vomiting compared to opoid based anaesthesia. This study compares opioid sparing effect of dexmedetomidine in conjunction with ultrasound-guided right external oblique intercostal nerve block and bilateral rectus sheath block for elective laparoscopic cholecystectomy against conventional opioid based technique.

Objective of the study is to measure total rescue opioid requirement in intraoperatiev and post operative period in using dexmetomidine infusion compared to conventional opioid based anaesthesia. Incidence of any post operative nausea vomiting, and any complication is also compared. Time to extubation and post operative pain scores are also compared

This is a prospective open label randomised control study conducted in Aster CMI Hospital, Bangalore, in 78 patients between 18 to 65years undergoing elective Laparoscopic Cholecystectomy surgery belonging to ASA 1 and ASA2. Any patients having contraindication to study drugs is excluded from the study.

One group  of patients are given Dexmedetomidine infusion with loading dose 0.3mcg/kg for 10min at induction of anaesthesia, followed by 0.5mcg/kg/hr. Other group will be given Fentanyl 2mcg/kg at induction. Both groups will be premedicated with Midazolam, glycopyrolate, and general anaesthesia induced with titrated dose of Propofol and atracurium. Preincisional ultrasound guided right External oblique intercostal plane block and bilateral ultrasound guided rectus sheath block is also given. Inj Fentanyl 25mcg boluses will be given as rescue analgesic intraoperatively. Inj Paracetamol and Diclofenac is also used intraoperatively.

Perioperative vitals, total Fentanyl usage, post operative pain scores and any incidence of complication will be measured, analysed and compared

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing elective laparoscopic cholecystectomy surgery Patients under ASA 1 and ASA2 class Baseline Heart rate more than 50beats per minute.

排除标准

  • Patients of ASA 3 and above Patient refusal Patients on betablocker drugs Patient with history of Cardiac arrhythmia Patients with deraged renal function Any history of allergy to any of study drugs Patients with history of bronchial asthma Patients at risk of aspiration Pregnant and lactating mothers.

结局指标

主要结局

Total (intraoperative and postoperative) rescue Fentanyl usage for analgesia when using Dexmedetomidine infusion compared to conventional opioid based anesthesia.

时间窗: Total usage at 0hour post procedure | total usage till 24hour post procedure

次要结局

  • incidence of postoperative nausea & vomiting(post operative period till 24 hours)
  • time to extubation and eye opening to call(intraoperative)
  • any complication associated with dexmedetomidine or opioid(intraoperative & post operative period till 24 hours)

研究者

发起方
Adarsh K P
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Adarsh K P

Aster CMI Hospital

研究点 (1)

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