Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- treating post spinal shivering
研究概览
简要总结
Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
详细描述
Shivering is known to be a frequent complication, reported in 40 to 70% of patients undergoing surgery under regional anaesthesia. 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.Post cesarean section spinal shivering is frequent. It causes involuntary muscular contractions and pain. Shivering, or muscular contractions, may be moderate or severe and persist for varying lengths. Anesthesia and body temperature fluctuations may produce post-spinal shivering. Properly managing post-spinal shivering improves patient outcomes and satisfaction.
Granisetron and pethidine treat post-spinal shivering. Granisetron blocks acetylcholine, a neurotransmitter that contracts muscles. Pethidine inhibits norepinephrine. Both drugs reduce post spinal shivering. However, the efficacy of granisetron and pethidine in treating post-cesarean spinal shivering has not been adequately explored.
Patients will undergo spinal anesthesia via the administration of 2.5ml of Bupivacaine 0.5% intrathecally using a 25-gauge spinal needle. The patients will be continuously monitored for any episodes of shivering, nausea, and vomiting. Vital data of the patients will also be closely monitored including oxygen saturation, pulse rate, blood pressure, respiratory rate and temperature at 10 minutes intervals throughout the operation and the stay in the recovery room. (PACU time around 30 minutes)
If shivering occurs the degree of Shivering will be classified as:
- 0: No shivering
- 1: Mild fasciculations of face or neck and ECG disturbances in the absence of voluntary activity of the arms
- 2: Visible tremor involving more than one muscle group
- 3: Gross muscular activity involving the entire body
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •elective for caesarian section presence of post-spinal shivering, defined as involuntary muscle contractions occurring within operative and early recovery period after cesarean delivery.
- •Age 18 - 45
- •Exclusion Criteria
- •Inability to provide informed consent.
- •Previous allergies or sensitivities to granisetron or pethidine.
- •Current use of medications that may interact with granisetron or pethidine.
- •Presence of other conditions that may contraindicate the use of granisetron or pethidine, such as known liver or kidney disease.
- •Patients who are too short (<140 cm) or too tall (>190 cm)
排除标准
- 未提供
研究组 & 干预措施
granisetron group
will receive granisetron 3 mg iv bolus
干预措施: Granisetron 1 Mg/mL Intravenous Solution (Drug)
pethidine group
will receive pethidine 25 mg iv bolus
干预措施: Pethidin (Drug)
结局指标
主要结局
treating post spinal shivering
时间窗: perioperatively/periprocedurally
If shivering occurs the degree of Shivering will be classified as: * 0: No shivering * 1: Mild fasciculations of face or neck and ECG disturbances in the absence of voluntary activity of the arms * 2: Visible tremor involving more than one muscle group * 3: Gross muscular activity involving the entire body assessment of tested drugs in treating post spinal shivering in patients who undergone cesarean delivery and have been treated with either granisetron or pethidine
次要结局
- nausea, vomiting(12 hours postoperative)
- pain assessment(12 hours postoperative)
研究者
Khaled Abdou
associated professor
Ain Shams University