Prophylactic Granisetron for the Prevention of Spinal Induced Shivering During Cesarean Section: a Prospective Double Blind Dose Ranging Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- shivering score
研究概览
简要总结
This study compares the efficacy of two different doses of intravenous (IV) granisetron on the prevention of postspinal shivering during cesarean section, in comparison with placebo.
详细描述
The study will includes four groups as follows:
- Granisetron1 group: women will receive 1mg IV granisetron
- Granisetron 0.7 group: women will receive 0.7 mg IV granisetron and
- Control group: women will receive 2 ml of 0.9% sodium chloride. Throughout the study period,shivering scores, core temperature, sensory level and motor block will be recorded, heart rate will be measured continuously using an electrocardiogram; blood pressure will be determined. If heart rate decreases by more than 20% of the baseline atropin will be received and if blood pressure decreases 20% of the baseline ephedrine will be received.
Also, Apgar score at one minute and five minutes will be recorded. At the end patient satisfaction will be assessed using Verbal Numeric Scoring system Side effects (bradycardia, hypotension, hypothermia, nausea and vomiting, pruritus etc ) will be recorded perioperatively in the operating room and postanesthetic care unit.
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)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women at term,
- •ASA status I or II (American Society of Anesthesiologists) physical status class I-II,
- •low-risk cesarean section,
- •Scheduled for the spinal anesthesia
排除标准
- •Pregnant women in labor
- •Patients who have the body temperature over 37.3 or less than 37 celsius degree
- •Known allergies to the study drugs
- •Contraindication to spinal anesthesia
研究组 & 干预措施
Granisetron 1
Intravenous granisetron 1 mg
干预措施: Granisetron (Drug)
Granisetron 0.7
Intravenous granisetron 0.7 mg
干预措施: Granisetron (Drug)
Placebo
intravenous 0.9% Sodium chloride (2 ml)
干预措施: Sodium chloride (Drug)
结局指标
主要结局
shivering score
时间窗: 180 min (immediately before the block till 180 min after the block)
次要结局
- non invasive blood pressure(90 min (immediately before the block till 90 min after the block))
- core temperature(90 min (immediately before the block till 90 min after the block))
- heart rate(90 min (immediately before the block till 90 min after the block))
研究者
Seham Mohamed Moeen Ibrahim
lecturer
Assiut University