Comparison Between Two Different Doses of Ondansetron on the Incidence of Spinal Shivering During Cesarean Section
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 主要终点
- incidence of shivering
研究概览
简要总结
Shivering is one of the most frequent complications occurring during or after spinal anesthesia with many side effects. The aim of the present study was to compare between two different doses of ondansetron for anti-shivering effect
详细描述
Shivering is one of the most frequent complications occurring during or after spinal anesthesia, it affects about 40%-60 % of patients under spinal anesthesia. Intra and Post spinal shivering is distressing for the patients and anesthetist. Shivering may aggravate medical conditions in patients with limited cardiac or respiratory functions. It increases tissue oxygen demand many folds which in turn leads to increase the load on respiratory and cardiac systems to cope with increased aerobic metabolism. Shivering interferes with good patient monitoring by causing artifacts of electrocardiography, invasive and non-invasive blood pressure, pulse oximetry, etc... . Postoperatively shivering may cause discomfort to the patient, increases wound pain by stretching incision, increase the incidence of bleeding and infection.
We aim to compare the prophylactic use of two different doses of ondansetron on the incidence of shivering after spinal anesthesia in patients scheduled for lower limb surgery.
The primary outcome was percentage of patients suffering from shivering after spinal anesthesia, secondary outcomes include any side effects related to both doses.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-65 years
- •Both sexes
- •American Society of Anesthesiologists
- •physical status I and II
- •scheduled for lower limb surgery under spinal anesthesia
排除标准
- •Uncooperative patients
- •psychologically unstable patients
- •obese patients with BMI >30 preoperative use of ondansetron, or opioids Fever Patients with some clinical conditions like hypo- or hyperthyroidism, Parkinson's disease.
研究组 & 干预措施
normal saline
patients received normal saline for prevention of shivering during spinal anesthesia
干预措施: Normal saline (Drug)
ondansetron 4MG
patients received 4 mg of ondansetron for prevention of spinal shivering
干预措施: Ondansetron 4 MG (Drug)
ondansetron 8MG
patients received 8 mg of ondansetron for prevention of spinal shivering
干预措施: Ondansetron 8mg (Drug)
结局指标
主要结局
incidence of shivering
时间窗: for 24 hours after spinal anesthesia
Incidence of shivering among patients in both groups
次要结局
- Axillary temperature(for 24 hours after spinal anesthesia)
- incidence of nausea and vomiting(for 24 hours after spinal anesthesia)
- core temperature(for 24 hours after spinal anesthesia)
- incidence of hypotension(for 24 hours after spinal anesthesia)
研究者
Khaled Abdel-Baky Abdel-Rahman
lecturer
Assiut University
