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临床试验/NCT07651488
NCT07651488已完成1 期

Evaluation of Intrathecal Hyperbaric Bupivacaine With Dexmedetomidine in Adults Undergoing Perianal Surgery

Liaquat National Hospital & Medical College1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年3月29日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Duration of analgesia

研究概览

简要总结

The aim of this study is to evaluate the effects of adding 5-mcg dexmedetomidine to hyperbaric bupivacaine in our population as it has never been published before, to enhance the duration of analgesia after perianal procedures requiring spinal saddle block and, thus reducing requirements of postoperative analgesics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective perianal surgery under spinal saddle block were included in the study.
  • Age between 40-80 years
  • ASA status I and II

排除标准

  • Pregnant women
  • Patient with coagulopathy
  • Infection at or near the needle insertion site
  • Allergy to the trial drug
  • Patient with chronic pain
  • Cognitive impairment
  • Patient with known drug or substance abuse

研究组 & 干预措施

Dexemedetomidine

Experimental

Experimental group received intrathecal dexmedetomidine 5 microgram added to 5 mg of 0.5% hyperbaric bupivacaine in dextrose injection

干预措施: Dexmedetomidine (Drug)

Hyperbaric bupivacaine

Active Comparator

Active comparator had 5 mg of 0.5% hyperbaric bupivacaine in dextrose injection alone

干预措施: Hyperbaric bupivacaine % 0.5 (Drug)

结局指标

主要结局

Duration of analgesia

时间窗: 0 hour to 4 hours

duration of analgesia was assessed from induction of anesthesia till patient discharge

次要结局

  • Pain score(Two hours post surgery till 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fahad Ali Tunio

Principal Investigator

Liaquat National Hospital & Medical College

研究点 (1)

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