Comparison of Intravenous Ondansetron and Low Dose Ketamine in Preventing Post Spinal Shivering
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Frequency of Post Spinal Shivering
研究概览
简要总结
This randomized controlled trial assessed whether intravenous ondansetron is more effective than low dose ketamine in preventing shivering after spinal anesthesia in adults undergoing elective surgery. Post spinal shivering is a frequent and uncomfortable complication of spinal anesthesia and may increase oxygen demand and interfere with routine monitoring. Adults aged 20 to 70 years (body weight 50 to 80 kg; American Society of Anesthesiologists class I to II) scheduled for elective procedures under standardized spinal anesthesia were randomly allocated in equal numbers to receive either ondansetron 8 mg intravenously or ketamine 0.25 mg/kg intravenously, administered 5 minutes after the spinal injection. Perioperative temperature management was standardized for all participants. The primary outcome was the occurrence of post spinal shivering during intraoperative monitoring. Among 180 participants, shivering occurred in 30.0% of those receiving ondansetron and 44.4% of those receiving ketamine, showing a statistically significant reduction with ondansetron.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either gender aged 20-60 years with ideal body
- •weight of 50 to 80 kg.
- •Patients meeting ASA classification I and II determined by
- •anesthesiologist.
- •Patients undergoing elective surgeries under spinal anesthesia.
- •Duration of surgery should not be more than 3 hours.
排除标准
- •Patients having a documented history of severe adverse reactions to ketamine or ondansetron.
- •Patients with cardiovascular disease documented in history.
- •Patients with hepatic disease documented in history and supported by lab results (AST 32-40U/L), ALT(10-40U/L).
- •Patients with renal disease documented in history and supported by lab results. Urea (10-50mg/dl) S/Creatinine (0.3-1.5mg/dl).
- •Patients with hyperthyroidism documented in history and supported by lab results.
- •Patients with history of mental illness, seizures and glaucoma.
- •Patients with known hypertension (BP greater than 140/90).
- •Haemodynamically unstable patients (BP<100mmHg).
- •Patients with coagulopathy or other bleeding diathesis documented in history and supported by lab results.
- •Complicated prolonged surgeries in spinal anesthesia.
研究组 & 干预措施
Group Ondansetron
Received 8 mg of ondansetron administered intravenously five minutes after spinal anesthesia for prophylaxis of post spinal shivering.
干预措施: ondansetron (Drug)
Group Low Dose Ketamine
Received ketamine 0.25 mg per kilogram administered intravenously five minutes after spinal anesthesia for prophylaxis of post spinal shivering.
干预措施: Ketamine (0.25 mg/kg) (Drug)
结局指标
主要结局
Frequency of Post Spinal Shivering
时间窗: From 5 minutes after administration of study drug until transfer of the patient to the post-anesthesia care unit
Occurrence of post spinal shivering following administration of study medication, assessed clinically by the anesthesiology team and recorded as present or absent during intraoperative monitoring after spinal anesthesia.
次要结局
未报告次要终点
研究者
Adeel Ahmed
Principal Investigator
Mayo Hospital Lahore