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临床试验/CTRI/2014/08/004806
CTRI/2014/08/004806已完成Unknown

COMPARISON OF ANALGESIC EFFICACY OF DEXMEDETOMIDINE VERSUS FENTANYL AS AN ADJUNCT TO THORACIC EPIDURAL WITH BUPIVACAINE IN PATIENTS UNDERGOING UPPER ABDOMINAL SURGERY

PostGraduate institute of medical education and research1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年2月5日最近更新:

试验速览

阶段
Unknown
状态
已完成
入组人数
40
试验地点
1
主要终点
postoperative pain and analgesic requirements

研究概览

简要总结

the purpose of the study was to compare and quantify the analgesic efficacy of dexmedetomoidine and fentanyl when both were used as an adjunct to thoracic epidural in patients undergoing hepaticojejunostomy under general anaesthesia. the addition of dexmededtomidine to 0.125% bupivacaine intraoperatively and postoperatively significantly reduces the requirement of bupivacaine as compared to fentanyl with comparable hemodynamic stability. the total consumption of rescue analgesia was significantly lower in dexmedetomidine group as compared to fentanyl group. the postoperative pain scores were comparable throughout the study between two groups and patients in dexmedetomidine group were more sedated.The heart rate was significantly lower in dexmedetomidine group as compared to fentanyl though the other haemodynamic parameters were comparable throughout the study.two patients in fentanyl group developed PONV whereas 2 patients in dexmed group developed mild nausea.no other side effects were reported in either of the two groups.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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

  • ASA Class I and II, undergoing elective hepaticojejunostomy.

排除标准

  • •BMI>35 kg/sq metre •Renal or hepatic dysfunction •Known cardiovascular disorder •Patients on beta-blockers, on long term treatment of antipsychotic drugs •Known allergy or senstivity to dexmedetomidine, bupivacaine or fentanyl •Contraindication to insertion of epidural catheter (local infection, spine deformities etc.) •Alcohol abuse, heavy smoking •Inability to use PCEA device.

结局指标

主要结局

postoperative pain and analgesic requirements

时间窗: 24 hours postoperatively

次要结局

  • intraoperative analgesia and hemodynamic parameters(assessed every 5 min after start of epidural infusion for 30 min ,every 15 min till end of surgery.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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