The Comparison of Hyperbaric Bupivacaine Plus Fentanyl and Hyperbaric Levobupivacaine Plus Fentanyl Administered Intrathecally in Patients Undergoing Elective Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- evaluation of the changes in mean arterial blood pressure between two groups.
研究概览
简要总结
Aim of the Study To compare the effects of hyperbaric bupivacaine plus fentanyl with hyperbaric levobupivacaine plus fentanyl on spinal block quality, haemodynamics and need for analgesics in patients undergoing elective cesarean section. Our hypothesis is that hyperbaric levobupivacaine will provide equal block quality, but better haemodynamic conditions compared to hyperbaric bupivacaine.
详细描述
Material - Method 60 patients, American Society of Anesthesiology (ASA) group I-II, between the ages of 18-45 who were scheduled for elective cesarian section under regional anesthesia are going to be included. Patients with contraindications to regional anesthesia, known allergy, suffering from pregnancy induced hypertension or placenta previa will be excluded from the study.
Patients will not be premedicated. After routine monitorization , IV access and fluid replacement patients will be separated to two groups on a randomised manner. Under sterile conditions spinal anesthesia will be performed in the sitting position at the level L3-4 or L 4-5 via epidural-spinal combined including a 27 G spinal needle.
Group 1 will receive 8 mg hyperbaric bupivacaine plus 20 mcg fentanyl /2ml intrathecally.
Group 2 will receive 8 mg hyperbaric levobupivacaine plus 20 mcg fentanyl/2ml intrathecally.
The Hyperbaric form of Levobupivacaine is not available on market , so it will be prepared with the addition of % 30 dextrose by another anesthesiologist who will be blinded to the patients.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •elective cesarean section no other coexisting medical situation
排除标准
- •known contraindication to regional anesthesia coexisting pregnancy induced problem placental mislocation known allergy
研究组 & 干预措施
Hyperbaric levobupivacaine
Group 2 Hyperbaric levobupivacaine % 0.5 plus fentanyl; 2 ml total intrathecally
干预措施: Hyperbaric levobupivacaine (Drug)
Hyperbaric bupivacaine
Group 1 Hyperbaric bupivacaine % 0.5 plus fentanyl 2 ml intrathecally
干预措施: Hyperbaric bupivacaine % 0.5 (Drug)
结局指标
主要结局
evaluation of the changes in mean arterial blood pressure between two groups.
时间窗: 6 month
次要结局
- Time to reach T4 dermatome(6 months)
研究者
Ozlem Sagir, MD
Assistant Professor
Balikesir University