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临床试验/CTRI/2016/09/007245
CTRI/2016/09/007245招募中不适用

post operative analgesic effect of infiltration of bupivacaine and dexmedetomidine in surgical wound- A randomised placebo controlled trial

Indira Gandhi Institute of Medical Sciences Sheikhpura Patna1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年12月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
pain score by visual analogue score

研究概览

简要总结

A total of ninety patients will be enrolled, those aged between 15 - 60 years; of ASA status 1 and 2 and undergoing elective abdominal surgeries. They will be randomised into three groups; receiving placebo, bupivacaine (25 ml of 0.25%) and dexmedetomidine (1 mcg/kg dexmedetomidine added to 25 ml of 0.25% bupivacaine) at the end of surgery. pain at rest and on cough will be assessed up to 24 hours after surgery. rescue analgesia will be given with i.v. tramadol 1.5 mg/kg. number of patients requiring rescue analgesia and total consumption of tramadol will be recorded. level of sedation will be assessed using 4 point sedation scale. any adverse effects like nausea/vomiting, hypotension, bradycardia, dry mouth, dizziness, diplopia will be recorded.

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

入选标准

  • •Age 15 to 60 years.
  • •ASA grade I &II •Elective open abdominal surgeries, namely open cholecystectomy, nephrectomy, pyeloplasty.

排除标准

  • •Cardiopulmonary diseases •Hepato-renal insufficiency •Patients receiving adrenoceptor agonists, antagonists, narcotics, or NSAIDS prior to surgery.
  • •Raynauds disease •Morbid obesity.

结局指标

主要结局

pain score by visual analogue score

时间窗: 24 hours

次要结局

  • sedation level(24 hours)

研究者

发起方
Indira Gandhi Institute of Medical Sciences Sheikhpura Patna
申办方类型
Government medical college

研究点 (1)

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