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临床试验/CTRI/2024/10/075777
CTRI/2024/10/075777尚未招募不适用

A comparative study of prophylactic Tramadol, Ketamine and Ondansetron in the prevention of intraoperative shivering in patients undergoing lower limb orthopaedic surgeries under spinal anaesthesia.

M Thangadurai1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2024年11月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
93
试验地点
1
主要终点
Incidence of shivering

研究概览

简要总结

Shivering is a normal thermoregulatory mechanism in patients undergoing spinal anaesthesia. Spinal anaesthesia impairs the thermoregulatory system by inhibiting vasoconstriction, which plays an important role in temperature regulation. Spinal anaesthesia also results in redistribution of core heat to the periphery from the trunk below the level of block. Both these effects predispose patients undergoing spinal anaesthesia to hypothermia and shivering. Studies in recent years have shown that even mild hypothermia (10C – 20C) can triple the incidence of adverse cardiac outcomes. Besides, other serious outcomes of post-spinal shivering are an increase in surgical blood loss, increase in need for blood transfusion, increase in oxygen consumption and carbon dioxide production by two to three fold, increased catecholamine production, lactic acidosis, increase in intraocular pressure, intracranial pressure etc. Shivering also creates difficulty in monitoring the patients as most of the multi parameter monitors used for anesthesia show erroneous values. Intravenous Tramadol has been found to be effective in reducing the incidence of post spinal anesthesia intraoperative shivering. Tramadol is a opioid class of drug, mu opioid agonist with minimum effect at kappa and delta receptors. It also inhibits the reuptake of serotonin and norepinephrine at the spinal cord level, which increases 5-OH Tryptamine production. Above actions of Tramadol make it effective in preventing and controlling post spinal anaesthesia shivering. Ketamine is also effective in prevention of intraoperative shivering. Ketamine acts as NMDA receptor antagonist and it decreases core to peripheral redistribution of heat by direct central sympathetic stimulation and by blocking inhibition of norepinephrine uptake into post ganglionic sympathetic nerve endings. Above actions make Ketamine effective in prevention and controlling post spinal anaesthesia shivering. Ondansetron has also been found to be effective in prevention of intraoperative shivering. Ondansetron is 5-HT3 antagonist. It is proposed to act centrally at the level of preoptic anterior hypothalamic region by inhibition of serotonin reuptake in prevention of intraoperative shivering. There is a lack of study in comparing the efficacy of Tramadol, Ketamine and Ondansetron in preventing post spinal anesthesia shivering. Therefore, this study will be conducted to compare the efficacy of Tramadol, Ketamine and Ondansetron in preventing post-spinal intraoperative shivering.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Double

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Patients of age 18-45 years.
  • Either sex.
  • ASA physical status I & II undergoing elective lower limb orthopaedic surgeries under spinal anaesthesia.

排除标准

  • Patients having contraindications for spinal anaesthesia like lack of consent, raised intracranial tension, infection at local site, severe aortic stenosis, coagulopathy, cardiovascular instability.
  • Patients with known allergy to study drugs.
  • Patients with BMI > 30 kg/m
  • Patients ASA physical status III or more.
  • Patients having major cardiovascular, respiratory, renal, hepatic, metabolic, neurological or endocrine diseases.
  • Patients with failed spinal anaesthesia.
  • Patients requiring general anaesthesia.
  • Patients having history of convulsion.
  • An initial or core temperature more than 37.5 C or less than 35.5 C.
  • Patients receiving intraoperative blood transfusion.
  • Patients receiving tramadol, ketamine or ondansetron in the pre-operative period.
  • Patients having arrhythmia or prolonged QTc.
  • Patients with history of opiod/alcohol /substance abuse.

结局指标

主要结局

Incidence of shivering

时间窗: 12 months

次要结局

  • 1. Severity of intraoperative shivering.(2. incidence of other side effects like nausea, vomiting, sedation.)

研究者

发起方
M Thangadurai
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

M Thangadurai

Calcutta National Medical College and Hospital

研究点 (1)

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