Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia for Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Maximum cephalad sensory blockade to pinprick, cold and touch
研究概览
简要总结
Several factors influence the extension of anesthetic mixture during spinal anesthesia including anesthetic gravity, body position, drug volume, and drug-delivering velocity. However, the effect of temperature of anesthetic mixture on the cephalad sensory blockade is hitherto unknown. The investigators hypothesized that different temperatures of the anesthetic mixture had different velocity of extension after spinal anesthesia. In addition, previous studies suggest that parturients have relative higher sensitivity to temperature. Herein the investigators proposed that the temperature of anesthetic mixture had more extensive effect on the cephalad sensory blockade with spinal anesthesia for cesarean delivery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous women
- •> 18 years and < 45 years
排除标准
- •Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
- •Participants younger than 18 years or older than 45 years
- •Those who were not willing to or could not finish the whole study at any time
- •Alcohol addictive or narcotic dependent patients
- •Subjects with a nonvertex presentation
- •Diagnosed diabetes mellitus and pregnancy-induced hypertension
- •Twin gestation and breech presentation
- •Pregnant fever
研究组 & 干预措施
1
Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 20 degree celsius
干预措施: bupivacaine/fentanyl/morphine (Drug)
2
Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 10 degree celsius
干预措施: bupivacaine/fentanyl/morphine (Drug)
3
Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 15 degree celsius
干预措施: bupivacaine/fentanyl/morphine (Drug)
4
Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 25 degree celsius
干预措施: bupivacaine/fentanyl/morphine (Drug)
5
Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 30 degree celsius
干预措施: bupivacaine/fentanyl/morphine (Drug)
6
Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 35 degree celsius
干预措施: bupivacaine/fentanyl/morphine (Drug)
结局指标
主要结局
Maximum cephalad sensory blockade to pinprick, cold and touch
时间窗: From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia
次要结局
- Velocity of the sensory blockade at identical body position(From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia)
- The total dose of phenylephrine required to maintain baseline arterial blood pressure(From the delivery of anesthetic mixture to 25 min after spinal anesthesia)
- Time interval of the occurrence of the hypotension(From the delivery of the anesthetic mixture to 25 min after spinal anesthesia)
研究者
Fu Zhou Wang
Dr
Nanjing Medical University