Single Bolus Intravenous Ephedrine Attenuates Reduction of Core Body Temperature in Patients Undergoing Spinal Anesthesia for Arthroscopic Knee and Ankle Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Tympanic temperature
研究概览
简要总结
A prospective double-blinded randomized controlled study to determine efficacy of ephedrine in preserving core temperature in patients under neuraxial spinal anesthesia for knee and ankle arthroscopic surgery.
详细描述
To determine the effect of ephedrine on preserving core temperature (tympanic) when given at finishing of local anesthetic administration for spinal neuraxial anesthesia comparing to normal saline (120 minutes period)
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing knee or ankle arthroscopic surgery under spinal block at department of orthopaedic Ramathibodi Hospital
- •BMI 17-30 kg/m2
- •ASA physical status 1-3
- •Age 18-70
- •Last oral intake more than 6 hours (2 hours for water)
- •Consent form acquired
排除标准
- •Patient who are contraindicated for spinal block
- •Anesthesia level higher than T4 or lower than T10
- •Tympanic temperature more than 37.5 or less than 35.5 degrees Celsius
- •Otitis or other ear infection
- •Patients who receive alpha adrenergic blocker or beta adrenergic blocker
- •Initial blood pressure presenting in operating theater 140 90 mmHg repeat after rest 5 minutes
- •Patient refusal
研究组 & 干预措施
Ephedrine
Intravenous 9 mg of ephedrine (3 ml) given at finishing local anesthetic administration for spinal anesthesia
干预措施: Ephedrine (Drug)
NSS
Intravenous normal saline 3 ml given at finishing local anesthetic administration for spinal anesthesia
干预措施: NSS (Drug)
结局指标
主要结局
Tympanic temperature
时间窗: 120 minutes
Diffference of changes in tympanic membrane temperature at time points compare with baseline (before spinal block) between two groups
次要结局
- Blood pressure(120 minutes)
- Shivering(120 minutes)
研究者
Thanist Pravitharangul
MD
Ramathibodi Hospital