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临床试验/CTRI/2024/03/064407
CTRI/2024/03/064407尚未招募4 期

A prospective randomized controlled study comparing intrathecal dexmedetomidine and intrathecal fentanyl for the prevention of post-spinal anaesthesia shivering in endoscopic urosurgical cases.

Sri Narayani Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年3月30日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Assess the incidence and severity of shivering

研究概览

简要总结

Spinal anaesthesia is a common technique for uroscopic procedures. Shivering is a common side effect after spinal anaesthesia due to inhibition of tonic vasoconstriction thereby causing redistribution of heat from trunk to peripheral areas. It is  more common in endoscopic surgeries due to absorption of large amount of cold irrigating fluids. Shivering is an involuntary , spontaneous and repetitive activity of the muscles. It leads to patient distress, impairment in monitoring , increased oxygen consumption and  carbon dioxide production. Dexmedetomidine is a highly selective alpha 2 adrenorecptor agonist which decreases the sympathetic tone. Side effects include hypotension , bradycardia, drymouth and nausea. fentanyl is a phenylpiperidine derivative synthetic opioid. It ha effect on spinal afferent thermal inputs and thermoregulator at spinal cord. side effects include hypotension, bradycardia, urinary retention, pruritis, nausea and vomiting. In this study we will compare the incidence and grades of shivering , duration of sensory block , hypotension, bradycardia, nausea and vomiting between 3 groups group D receiving intrathecal dexmedetomidine , group F receiving intrathecal fentanyl and group C receiving normal saline as adjuvants with 12.5- 15 mg of 0.5% heavy bupivacaine.

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 70.00 Year(s)(—)
性别
All

入选标准

  • patients undergoing endoscopic urosurgical procedurs like URS and TURP
  • ASA grade 1 and 2
  • surgical procedure expected to last less than 3 hours.

排除标准

  • patient with absolute contraindication to spinal anaesthesia
  • patient refusal
  • known allergy to any of the study drugs
  • ASA grade 3 and onwards
  • thyroid disease, parkinsons disease
  • patients on beta blockers
  • prostate size more than 100cc.

结局指标

主要结局

Assess the incidence and severity of shivering

时间窗: baseline, every 5 minutes for first 30 minutes and every 15 minutes for next 2 hours 30 minutes. | minutes-0,5,10,15,30,45,60,75,90,105,120,135,150,165,180

次要结局

  • Assess the duration of sensory block & adverse effects such as hypotension, bradycardia, nausea & vomiting.(baseline, every 5 minutes for next 30 minutes and every 15 minutes for next 2 hours 30 minutes.)

研究者

发起方
Sri Narayani Hospital and Research Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR ILAKKIYA U

Sri Narayani Hospital And Research Centre

研究点 (1)

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