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临床试验/CTRI/2024/02/062910
CTRI/2024/02/062910尚未招募3 期

A comparative study of post operative analgesia using intra thecal Dexmedetomidine and fentanyl as adjuvant to bupivacaine in lower abdominal surgeries. A Randomized double blinded study

Konjengbam Reshmi Devi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月2日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the duration of postoperative Analgesia (demand of first rescue analgesia)in first 24 hours

研究概览

简要总结

The study will be a prospective randomized double-blinded study to assess and compare the effects of intrathecal administration of low dose of 10mg hyperbaric Bupivacaine with 5 mcg dexmedetomidine and 10 mg hyperbaric Bupivacaine with 12.5 mcg fentanyl. A total of 60 patients will be selected for the study and divided into 2 groups of 30 patients each Group A (n-30) and Group B (n-30). According to a computer-generated randomization table, patients in group A will be administered 2 ml of 0.5% bupivacaine heavy and 0.5ml (12.5µgm) fentanyl citrate and group B will be administered 2 ml of 0.5% bupivacaine heavy and 0.1 ml of 5 mcg dexmedetomidine in the subarachnoid space L3-L4. In both the groups, the study drugs will be administered at a rate of 0.2 ml/min. in the subarachnoid space L3-L4. The block characteristics along with regression of the blockade, side effects (if any) and the hemodynamic changes will be observed, assessed and recorded by blinded investigator using the VAS and sedation scale. The finding and observation made during the entire study will be tabulated graphically depicted whenever possible, statistically analysed and inference will be drawn to evaluate the duration of post-operative analgesia and side effects of the two study drugs.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anaesthesiologists (ASA) physical status I and II.
  • 18- 65 years of age.
  • Either sex.

排除标准

  • History of allergy to study drugs
  • Bleeding disorder
  • Local site infection
  • Cardiac,respiratory and kidney disorder,neurological deficit 5.Spinal deformity.

结局指标

主要结局

To compare the duration of postoperative Analgesia (demand of first rescue analgesia)in first 24 hours

时间窗: Outcome will be assessed at 24 hours post-op

次要结局

  • 1. Hemodynamic parameters- Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), oxygen saturation (spo2)(2. Adverse effects.)

研究者

发起方
Konjengbam Reshmi Devi
申办方类型
Other [[self]]
责任方
Principal Investigator
主要研究者

Konjengbam Reshmi Devi

Regional Institute of Medical Sciences, Imphal

研究点 (1)

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