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临床试验/CTRI/2017/09/009830
CTRI/2017/09/009830已完成不适用

A Prospective randomised double blinded trial comparing two doses of dexmedetomidine added to ropivacaine for paravertebral block during modified radical mastectomy for postoperative analgesia

Sangeeta Chakraborty1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Post operative analgesia intensity and duration

研究概览

简要总结

A comparative study where 60 patients were allocated in three groups. group A received 18 ml 0.75% ropivacaine with 1 mcg/kg dexmedetomidine, group B 18 ml ropivacaine 0.75% with 0.5 mcg/kg dexmedetomidine , group C (control) 18 ml 0.75% ropivacaine only in single site paravertebral block preoperatively in patients undergoing modifoed radical mastectomy for Ca breast. Then stansdard GA was given for proceeding with the surgery. Intraoperative and postoperative ,mean arterial pressure, heart rate, spo2 , side effects, complications and postoperative pain score and duration of analgesia in terms of time and amount of first rescue analgesic dose was compared among three groups. Three groups were comparable in terms of demography and baseline data. Intraoperatively the group receiving 1mcg/kg dexmedetomidine(group A) showed lower MAP and heart rate as compared to two other groups in most of the period , Whereas heart rate and SPO2 was mostly stable in other two groups(group B and C). Post operative pain score(VAS) along with duration of analgesia was better in both the groups receiving dexmedetomidine (group A and group B) as compared to the control group(group C) whereas these results were comparable between group A and B.

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
Female

入选标准

  • 未提供

排除标准

  • Patients who refrained from giving an informed consent
  • Those with spinal or chest wall deformity and/or local infection at site of block.
  • Patients with coagulopathy
  • Patients with hypersensitivity to either ropivacaine or dexmedetomidine
  • Patient who had cognitive abnormalities due to underlying psychiatric comorbidities or patients who were not cooperative.
  • Heart block, moderate or severe stenotic/regurgitant heart lesions.
  • Patient with BMI<18.5 or>30, height <150 cm and > 195 cm .

结局指标

主要结局

Post operative analgesia intensity and duration

时间窗: Just after the end of the surgery and then 4 hourly till 24 hours

次要结局

  • Heart rate, Mean Arterial Pressure, Spo2, side effects, complications, patient satisfaction(Intraoperatively and just after the end of the surgery and then 4 hourly upto 24 hours)

研究者

发起方
Sangeeta Chakraborty
申办方类型
Other [self]

研究点 (1)

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