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临床试验/CTRI/2024/07/070420
CTRI/2024/07/070420尚未招募2/3 期

Comparative evaluation of dexmedetomidine and lidocaine in postoperative analgesia in open cholecystectomy a double blind study

Dr Kamal Jyoti Kashyap1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年7月17日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Visual Analogue scale (VAS) scores at various time intervals, haemodynamic changes

研究概览

简要总结

Gallstone disease (cholelithiasis) is a major health problem in adult population. Open cholecystectomy is routinely performed in elective operation theatres. Postoperative pain is major cause of morbidity in postoperative period and it affects multiple organ systems. This study is designed to evaluate the effects of intravenous infusion of dexmedetomidine vs lidocaine for postoperative analgesia. Double blind randomized study will be performed on 80 patients with age 20-60 years ASA (American Society of Anaesthesiologist) grade I and II for open cholecystectomy under general anaesthesia. Patients in group L will receive Intravenous lidocaine 1.5mg/kg body weight followed by Infusion of 2mg/kg/hr. In group D, patients will receive 1mcg/kg dexmedetomidine followed by infusion of 0.4mcg/kg/hr. Patients will be kept in post anaesthesia care unit (PACU) for 24 hrs and pain will be assessed at regular intervals using visual analogue scale (VAS). Vitals will also be monitored at regular intervals. Post operative consumption of diclofenac and tramadol will be noted.The data will then be compiled, tabulated and statistically analyzed with latest software.

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • age 20-60 years ,American Society of Anaesthesiologists (ASA) grade I and II , posted for open cholecystectomy under general anaesthesia.

排除标准

  • Allergy to study drugs , obesity (BMI more than 35), renal failure , liver failure , pregnancy, alcohol abuse , chronic use of analgesic or other drugs , decreased autonomic control ,malampatti grade III and IV.

结局指标

主要结局

Visual Analogue scale (VAS) scores at various time intervals, haemodynamic changes

时间窗: hemodynamic parameters will be assesd during intraoperative period and Visual Analogue scale (VAS score) , hemodynamic parameter and requirements of rescue analgesia will be assesd post operative period for 24 hours

次要结局

  • Sedation score , time taken to achieve MPADSS ( Modified post anaesthestia discharge scoring system), time required for additional analgesia, measure requirements of rescue analgesia, total analgesic requirements in 24 hrs(From end of surgery till 24 hours postoperative)

研究者

发起方
Dr Kamal Jyoti Kashyap
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Dr Kamal Jyoti Kashyap

Government medical College Amritsar

研究点 (1)

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