Dosage of Intrathecal Hyperbaric Bupivacaine and the Incidence of Post Spinal Shivering in Cesarean Section: is There a Relation?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Shivering score
研究概览
简要总结
Shivering is very common after spinal anaesthesia. Many studies have investigated the role of adding adjuvants to the local anaesthetics to decrease the incidence of post-spinal shivering. Non of the studies n the literature review have investigated the role of different dose of local anaesthetic alone in reducing the incidence of post-spinal shivering. In the present study the investigators aimed to compare the effect of different local anaesthetic dose in reducing post-spinal shivering.
详细描述
After approval of the ethics committee, department of anaesthesia, Menoufia University and written informed consent, a hundred full-term pregnant ladies undergoing elective cesarean section were enrolled in this study.
The pregnant ladies were randomly assigned using a computerised software to one of two groups, low dose bupivacaine (LB) and high dose bupivacaine (HB), 50 patients each according to bupivacaine dose. Group LB received low dose bupivacaine (8 mg hyperbaric bupivacaine) Group HB received high dose bupivacaine (10 mg hyperbaric bupivacaine).
Vital signs including heart rate and mean arterial blood pressure intra-operatively until the end of surgery.
The severity of shivering was the primary endpoint. Shivering was graded using a scale: 0, no shivering; 1, piloerection but no visible muscle activity; 2, muscular activity in one group of muscle; 3, muscular activity in more than one muscle group but not generalized movement; and 4, shivering involving the movement of the whole body. Shivering score was recorded for the whole study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 22 and 35 year old, and American Society of Anesthetists (ASA) I or II were included in the study and consented to have spinal anaesthesia for their section.
排除标准
- •Patients who had contraindication to spinal anesthesia, high-risk pregnancy, history of seizures, mental illness, acute fetal distress, and patients refused spinal anesthesia were excluded from the study.
研究组 & 干预措施
Low dose bupivacaine 0.5% (8mg)
Bupivacaine 0.5% for spinal anesthesia
干预措施: Low dose bupivacaine 0.5% (8mg) (Drug)
High dose bupivacaine 0.5% (10mg)
Bupivacaine 0.5% for spinal anesthesia
干预措施: High dose bupivacaine 0.5% (10mg) (Drug)
结局指标
主要结局
Shivering score
时间窗: Peri-operatively
Shivering score is a graded score using a scale: 0, no shivering; 1, piloerection but no visible muscle activity; 2, muscular activity in one group of muscle; 3, muscular activity in more than one muscle group but not generalised movement; and 4, shivering involving the movement of the whole body.
次要结局
- Heart rate (beat/minute)(Peri-operatively)
- Mean arterial blood pressure (mmHg)(Peri-operatively)
研究者
Dr Ezzeldin Ibrahim
Assistant Professor in anaesthesia, intensive care, and pain medicine.
Menoufia University