Efficacy of Intravenous Nefopam, Dexmedetomidine, and Meperidine in Preventing Post-Spinal Anesthesia Shivering in Adult Patients Undergoing Lower Abdominal and Lower Limb Surgeries: A Double-Blind Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- the incidence of shivering during the whole observation period
研究概览
简要总结
This prospective, randomized, controlled, double-blinded study is designed to evaluate the efficacy of nefopam compared to dexmedetomidine and meperidine for the prevention of postspinal anesthesia shivering while minimizing side effects.
详细描述
Numerous clinical studies have demonstrated that nefopam effectively prevents and treats postoperative shivering after general anesthesia. For instance, a dose of 0.15 mg/kg nefopam is comparable in efficacy to 0.5 µg/kg dexmedetomidine for treating shivering after orthopedic or abdominal surgery. Additionally, 20 mg of nefopam is equally effective as 50 mg of meperidine in preventing shivering following certain neurosurgical procedures . Notably, patients administered nefopam experience less sedation and hypotension compared to those given dexmedetomidine. However, further research is needed to evaluate nefopam's effects on preventing shivering after neuraxial blockades.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 21-60 undergoing elective lower abdominal, urological, gynecological, lower limb, orthopedic, or plastic surgeries under spinal anesthesia.
- •ASA physical status I and II.
排除标准
- •• Known hypersensitivity to nefopam, dexmedetomidine, or pethidine.
- •Thyroid disorders, psychiatric disorders, severe diabetes, or autonomic neuropathies
- •Known history of substance or alcohol abuse
- •A history of convulsive disorders or severe neurological diseases
- •Severe cardiac, pulmonary, renal, or hepatic disease
- •Obstetric procedures and procedures requiring transfusion of blood and blood products.
- •A contraindication to spinal anesthesia, e.g., coagulation disorders, local or general infection, increased intracranial tension, and progressive neurological disorders.
- •Failed or partial spinal block.
研究组 & 干预措施
nefopam group
• Group N (n=80) will receive nefopam 0.15 mg/kg i.v. (Nopain®, Medical Union Pharmaceuticals MUP, Ismailia, Egypt, Ampoules of 20 mg/1 ml)
干预措施: Nefopam (Drug)
dexmeditomidine group
• Group D (n=80) will receive dexmedetomidine 0.5 µg/kg i.v. (Precedex®, Hospira Inc, USA, Vials of 200 mg/2 ml)
干预措施: Nefopam (Drug)
meperidine group
• Group P (n =80) will receive pethidine (meperidine) 0.5 mg/kg i.v. (Ampoules of 50 mg/1 ml).
干预措施: Nefopam (Drug)
结局指标
主要结局
the incidence of shivering during the whole observation period
时间窗: 120 minutes
shivering score ≥ 3. The shivering score will be assessed at 10-minute intervals after the spinal block and graded by the scale validated by Wrench et al.
次要结局
- - Intraoperative hemodynamic variables(120 minutes)
- axillary body temperature(120 minutes)
- recurrent shivering(120 minutes)
研究者
Amany Ahmed Eissa
lecturer of anesthesia& ICU
Kasr El Aini Hospital