Dexmedetomidine Compared With Ondansetron in Treating Postanesthetic Shivering in Patients After Regional Anesthesia for Cesarean Section-a Randomized Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Period of time
研究概览
简要总结
Evaluate the efficiency of management with intravenous dexmedetomidine compared to intravenous ondansetron to achieve the disappearance of post-anesthetic shivering in a shorter time in the obstetric patient undergoing cesarean section under regional anesthesia.
详细描述
Randomized clinical trial with 40 pregnant patients, between 18 and 45 years old with ASA (American Society of Anesthesiologist) II or III, undergoing scheduled or emergency cesarean section with regional anesthesia and who presented grade tremor 1 based on the BSAS (Bedside shivering assessment scale) scale, at the Hospital Central from San Luis Potosi, Mexico. The main objective of this study was to quantify the time that elapsed from the end of the administration of the medication until the disappearance of the tremor, which was measured in minutes; The evaluation of the disappearance, persistence or reappearance of the tremor was solely visual by the anesthesiology staff.
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
- Single (Participant)
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
- •ASA II or III, undergoing scheduled or emergency cesarean section with regional anesthesia (hyperbaric bupivacaine 0.5% with morphine at 1 mcg Kg-1) and who presented tremor grade >1 based on the BSAS scale
排除标准
- •Hemodynamic instability, heart disease or sinus bradycardia, allergy to any of the medications applied, psychiatric diseases or hypothermia <35.2 ºC measured by tympanic temperature.
研究组 & 干预措施
Dexmedetomidine
0.3 mcg Kg-1 (actual weight) of dexmedetomidine IV in 20 mL of saline
干预措施: saline solution (Drug)
Ondansetron
8 mg ondansetron IV in 20 mL saline
干预措施: saline solution (Drug)
结局指标
主要结局
Period of time
时间窗: one hour
period of time in which post-anesthetic tremor is controlled from the moment of administration
次要结局
- Adverse effects(one hour)
研究者
MARIO AURELIO MARTÍNEZ-JIMÉNEZ
Doctor
Hospital Central "Dr. Ignacio Morones Prieto"