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临床试验/CTRI/2013/04/003600
CTRI/2013/04/003600已完成不适用

A study to compare the analgesic efficacy of intrathecal bupivacaine alone with intrathecal bupivacaine midazolam combination in patients undergoing elective infra-umbilical surgery

Institute of Post Graduate Medical Education and Reseach Kolkata1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2009年1月6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
90
试验地点
1
主要终点
Duration of analgesia

研究概览

简要总结

Background:Spinal anesthetic technique is one of the common procedures used for variousinfra umbilical surgeries. Duration of post operative analgesia is one of theimportant concerns while  performing thisprocedure. Several adjuvants have been tried along with local anesthetic forprolonging the duration of analgesia. In this study we have observed the effectof midazolam as an adjuvant in patients undergoing infra umbilical surgery.

Settingsand Design: A prospective, randomized, double blinded, parallel group, placebocontrolled, open label study tertiary care hospital.

Methods:90 adult patients aged 18 – 60 years, of American Society of Anaesthesiologists(ASA) status I and II, scheduled for elective infraumbilical surgery, were randomlyallocated in two groups. Each patient in group “B†received bupivacaine 12.5mg along with 0.4 ml of normal salinein the subarachnoid block, and patients of group “BM†received 12.5 mgbupivacaine along with preservative free midazolam 0.4ml (2mg). Duration ofanalgesia was calculated from time of administration of the block torequirement of rescue analgesic as demanded by the patient in the postoperative period.

Statisticalanalysis: SPSS v17.0 was used for analysis of data. A p-value < 0.05 wasconsidered statistically significant.

Results& conclusion: Use of midazolam as adjuvant with the local anestheticsignificantly increases the duration of analgesia and motor block but a lessPONV.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor 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

  • adult patients of ASA physical status I and II and aged 18 – 60 years undergoing elective infra-umbilical (gynaecologic/urologic) under spinal subarachnoid block anesthesia were included into the study.

排除标准

  • Patients refusing to participate, Patients with known allergic to local anaesthetic and midazolam, Patients suffering from chronic pain, and pregnant women.

结局指标

主要结局

Duration of analgesia

时间窗: time from administration of block to demand of first rescue analgesia in post operative period

次要结局

  • Duration of motor block(Hemodynamic changes)

研究者

发起方
Institute of Post Graduate Medical Education and Reseach Kolkata
申办方类型
Government medical college

研究点 (1)

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