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临床试验/CTRI/2024/02/062613
CTRI/2024/02/062613尚未招募1/2 期

To compare the effect of Ketamine spray versus Dexmedetomidine spray at surgical site during closure in lumbar spine fixation surgery for postoperative pain relief - Prospective, Randomized, double blinded, placebo controlled study

Institute of medical sciences banaras hindu university1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年2月28日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
入组人数
45
试验地点
1
主要终点
Duration of postoperative analgesia (VAS)

研究概览

简要总结

The patients will be divided randomly using computer generated number and concealed using sequentially numbered, sealed opaque envelope technique into three equal groups:

Group D: Will receive Dexmedetomidine 1 microgram/kg diluted in normal saline to make 20ml solution and is sprayed over the surgical site towards the end of the surgery.

Group K: Will receive Ketamine 1 mg/kg diluted in normal saline to make 20 ml solution and is sprayed over the surgical site towards the end of the surgery.

Group C: Will receive 20 ml of normal saline and is sprayed over the surgical site towards the end of the surgery.

 Under standard General anaesthesia, Lumbar spine surgery will be done,

towards the end of surgery once the fixation will be done, Dexmedetomidine 1mcg/kg or Ketamine 1 mg/kg or normal salinewill be diluted in 0.9% Normal Saline to make 20 ml solution. This solution will be sprayed over the surgical site, thoracolumbar fascia, subcutaneous tissue using drug atomizer device which will atomize the drug and skin closure will be done. Patient will be turned supine and extubation will be done. VAS will be monitored at 30 mins after extubation, 1hr, 2h, 4h, 6h and 24h post extubation.  Patients will be given rescue analgesia if VAS (≥4/10), with inj tramadol 2mg/kg asslow intravenous with prior medication with 0.1mg/kg Ondansetron. If pain still persist then Inj paracetamol 1 gm iv [max 4 gm in 24 h]will be given over 20min. Such demand in first 24 h will be monitored for the study.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Lumbar spine patients posted for spine instrumentation surgery.
  • Age group between 18 and 60 years.

排除标准

  • Refused to participate in the study.
  • A body mass index exceeding 30 kg/m2
  • Hepatic or Renal insufficiency
  • Multiple level spine surgery or simultaneous/recent surgery
  • Antihypertensive medication with clonidine or other α2 agonists.

结局指标

主要结局

Duration of postoperative analgesia (VAS)

时间窗: 30mins,hours: 1,2,4,6,24

次要结局

  • Total rescue analgesic requirement in 24hr.(Any associated side effects like nausea /vomiting/sedation/shivering etc.)

研究者

申办方类型
Government medical college

研究点 (1)

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