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临床试验/NCT05718011
NCT05718011已完成4 期

Comparison of Prophylactic Use of Dexmedetomidine and Ketamine for Prevention of Shivering After Spinal Anesthesia

Pakistan Air Force (PAF) Hospital Islamabad1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2021年2月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
116
试验地点
1
主要终点
Postoperative Shivering

研究概览

简要总结

Recently, ketamine and dexmedetomidine have been used to prevent shivering during anaesthesia, with good results. Ketamine (a competitive NMDA receptor antagonist) plays a role in thermoregulation at various levels and ketamine, has been shown to inhibit postoperative shivering in some reports and studies.

详细描述

Spinal anaesthesia is a safe and popular anaesthetic technique for various surgeries. Around 40-60% of the patients under spinal anaesthesia develop shivering.The main causes of shivering intra and postoperatively are temperature loss, decreased sympathetic tone and systemic release of pyrogens. Hypothermia during neuraxial anesthesia develops initially from core to peripheral redistribution of body heat. Redistribution of body heat during spinal or epidural anesthesia typically decreases core body temperature 0.5-1.0 degree Celsius.

Shivering is characterised by involuntary oscillatory contractions of skeletal muscles. Once the body is exposed to cold, it is a physiological response for heat preservation after peripheral vasoconstriction. Postoperative shivering is defined as the fasciculation of the face, jaw or head or muscle hyperactivity, lasting longer than 15 seconds. It is a common and challenging aspect of anaesthesia and targeted temperature modulation because it leads to increase oxygen consumption and increases the risk of hypoxia.

The most frequent complication in postoperative period is shivering which is reported to be between 20-70% after general anaesthesia. The incidence reported in previous studies are 5-65% after general anaesthesia and 30-33% after epidural procedures. The overall shivering incidence in a recent meta-analysis was 34%.

The underlying pathology of shivering is not fully understood yet, therefore the definitive treatment and prevention has not been established till date. Due to its importance as postoperative complication and the lack of available data about aetiology and treatment, this narrative review of the published literature on this topic is essential.

Various pharmacological agents being used for prophylaxis and treatment of post spinal shivering are Opioids like fentanyl, tramadol, pethidine, Anticholinergics like physostigmine, NMDA receptor antagonist like ketamine and the latest being alpha-2 antagonists like clonidine, dexmedetomidine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 20-50 years.
  • Both genders
  • ASA physical status I and II
  • Undergoing lower abdominal or lower limb surgeries under spinal anaesthesia

排除标准

  • Patients with history of thyroid and neuromuscular diseases
  • Patients with severe hypovolemia
  • Patients with febrile illness
  • Patients who required blood transfusion during surgery
  • Patients with body temperature ≤ 36˚C or ≥ 38˚C on thermometer

研究组 & 干预措施

dexmedetomidine

Experimental

0.5 micrograms/kg

干预措施: Dexmedetomidine (Drug)

ketamine

Active Comparator

0.5 milligram/kg

干预措施: Ketamine (Drug)

结局指标

主要结局

Postoperative Shivering

时间窗: Change in every 10 minutes after spinal anesthesia till PACU discharge after 01 hour PACU stay.

Visible muscle activity in more than one muscle group.

次要结局

未报告次要终点

研究者

发起方
Pakistan Air Force (PAF) Hospital Islamabad
申办方类型
Other
责任方
Sponsor

研究点 (1)

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