跳至主要内容
临床试验/CTRI/2025/12/099389
CTRI/2025/12/099389尚未招募不适用

Comparative assessment of Clonidine and Tramadol on controlling post-spinal anaesthesia shivering.

MS Ramaiah Medical College1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2026年1月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
128
试验地点
1

研究概览

简要总结

Spinal anaesthesia is widely used as a safe anaesthetic technique for both elective and emergency operations. Shivering is a frequent complication following spinal anaesthesia, affecting between 40% and 60% of patients who receive a subarachnoid block This high rate of post-spinal shivering (PSS) is largely due to hypothermia that develops during surgery. The spinal block causes blood vessels to dilate and inhibits the body’s natural ability to constrict them for temperature regulation below the block level, leading to a shift of heat from the core to the body’s extremities. Shivering is a potentially serious complication, resulting in increased metabolic rate, increased oxygen consumption (up to 100-600%) along with raised carbon dioxide (CO2) production, ventilation and cardiac output, adverse postoperative outcomes such as wound infection, increased surgical bleeding, and morbid cardiac events. It causes arterial hypoxemia, lactic acidosis, increased intraocular pressure (IOP), increased intracranial pressure (ICP) and interferes with pulse rate, blood pressure (BP) and electrocardiographic (ECG) monitoring. Different drugs like Pethidine, Clonidine, Ketamine, Tramadol, Butorphanol, Dexmedetomidine, Nalbuphine and Nefopam have been evaluated for the prevention and treatment of peri operative shivering. They are simple, cost effective and readily available. Among the various drugs for controlling shivering, Pethidine has been shown to be effective with a minimum dose of 0.35mg per kg body weight. However, it is associated with many undesirable side effects including post-operative nausea and vomiting and respiratory depression. Tramadol on the other hand at a dose of 1mg per kg body weight had also been shown to be effective in the treatment of post-anaesthetic shivering but the incidence of nausea and vomiting was high. Clonidine at a dose of 1mcg per kg body weight is also effective in controlling the shivering post-spinal anaesthesia, however there are incidences of Hypotension and decreased heart rate in the patients. Hence, the aim of the present study is to compare the efficacy of Clonidine an alpha 2-agonist with that of Tramadol, a non-opioid analgesic for control of shivering after spinal anaesthesia in patients undergoing lower abdominal and lower limb surgeries. In the present study we hypothesise that Clonidine is more efficacious than Tramadol in controlling the post-spinal anaesthesia shivering.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • ASA I and II patients posted for elective surgeries under spinal anaesthesia.
  • Patients who develop shivering.

排除标准

  • Refusal to consent for proposed study Infection at injection site History of any bleeding tendency, taking oral anticoagulants (INR more than 1.5) Uncontrolled comorbidities Allergy to the study drug Initial body temperature more than 38 degree celsius or less than 36 degree Celsius.
  • Spine deformity Severe pulmonary or cardiac or hepatic or renal disease Contraindications to spinal anaesthesia Pre-existing neurological deficits.

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sagar R Patil

MS Ramaiah Medical College

研究点 (1)

Loading locations...

相似试验