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临床试验/CTRI/2013/12/004219
CTRI/2013/12/004219已完成不适用

"Comparison between epidural Ropivacaine and Ropivacaine Clonidine combination for infraumbilical surgeries.A prospective,randomized clinical study"

DR NEERAJ KUMAR1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年2月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
The addition of 75 µg clonidine to isobaric epidural ropivacaine results in longer, complete and effective analgesia with similar block properties and helped to reduce the effective dose of ropivacaine when compared with plain ropivacaine for infraumbilical surgeries

研究概览

简要总结

Background:Neuraxial adjuvants augment the action of Local anaesthetics Aims and Objective:  Aim to determine the quqlitative and quantitative aspects of epidural ropivacaine 0.75% and epidural ropivacaine 0.75% clonidine 75mcg combination for infraumbilical surgeries Material and Methods: 80 patients of ASA-I and ASA-II grades aged between 18-60 years who underwent infraumbilical surgeries were included randomly into two clinical study groups comprising 40 patients in each study group.Epidural anaesthesia was administered with 20ml of ropivacaine 0.75%(GROUP-R) and 20 ml of epidural ropivacaine 0.75% and clonidine 75mcg combination(GROUP-RC).Parameters of observation are demographic data,onset of sensory ,onset of motor ,highest level of sensory block ,duration of motor block,duration of sensory analgesia and hemodynamic parameters like NIBP,HR,RR,SPo2 and adverse events were observed and recorded. Result: Eighty patients were enrolled in this study and were subjected to statistical analysis.Groups were comparable with regard to demographic data and incidences of side effects except for the higher incidence of dry mouth in patients of RC group.Onset of analgesia was much shorter in RC group with prolonged duration of analgesia.The incidences of bradycardia and hypotension was more in RC group as compared to R group which was statistically significant.The dose requirement for postoperative period [ain relief was significantly lesser in RC group. Conclusion: The addition of 75mcg clonidine to isobaric epidural ropivacaine results in longer,complete and effective analgesia with similar block properties and helped to reduce the effective dose of ropivacaine when compared with plain ropivacaine for infraumbilical surgeries.

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

  • I)Patient undergoing infraumbilical surgeries under regional anaesthesia II)ASA grade I and II patients.

排除标准

  • I)Patient Refusal II)ASA grade III and IV patients III)Any Hematological disorders IV)Any bleeding,Coagulation abnormalities or Full anticoagulant therapy V)Psychiatric disease ,DM,CAD any comorbid conditions VI)H/O drug abuse and drug allergy to LA of amide types VII)Any C/I to epidural anaesthesia.

结局指标

主要结局

The addition of 75 µg clonidine to isobaric epidural ropivacaine results in longer, complete and effective analgesia with similar block properties and helped to reduce the effective dose of ropivacaine when compared with plain ropivacaine for infraumbilical surgeries

时间窗: 4-5 hours

次要结局

  • not applicable(NA)

研究者

发起方
DR NEERAJ KUMAR
申办方类型
Other [INDIVIDUAL PATIENT]

研究点 (1)

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