Does the Reduction of Local Anesthetic Dose Provide Surgical Anesthesia While Avoiding Maternal Hypotension in Obese Pregnant for C/S by Single Shot Spinal Anesthesia?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- VAS score < 6 with only spinal anesthesia
研究概览
简要总结
Anesthesia for cesarean section requires special importance because it may affect both mother and the baby. To avoid maternal hypotension related to spinal anesthesia must be the primary objective during anesthesia. Even though many factors influence sensory nerve block for surgical anesthesia, local anesthetic dose is the main determinant. Another factor that influence the sensory nerve block is the obesity related to pregnancy. Due to the enlargement of epidural venous plexus related to pregnancy, the subarachnoid and epidural space reduces, so the local anesthetic requirement also reduces. Many investigators recommend lower dose of local anesthetic in obese patients due to reduced requirement There are many studies about dose regimens for cesarean anesthesia, but ideal dose have not been found. Investigators have designed this study to see the effects of conventional dose (10 mg bupivacaine) vs. low dose plus fentanyl (7,5 mg bupivacaine+25 mcg fentanyl) in obese and normal weight pregnant for cesarean section. The hypothesis was: the low dose regimen provides surgical anesthesia in obese patients while avoiding maternal hypotension.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patients
排除标准
- •Spinal anesthesia contraindications, thrombocytopenia, coagulation defects, cardiomyopathy, placenta previa, twin pregnancy, hypersensitivity to amide local anesthetics or fentanyl, infection at the injection site, neurologic disease.
研究组 & 干预措施
Group I
Pregnant with BMI<30 and having spinal anesthesia with 10 mg hyperbaric bupivacaine
干预措施: Bupivacaine (Drug)
Group II
Pregnant with BMI<30 and having spinal anesthesia with 7,5 mg hyperbaric bupivacaine+25 mcg fentanyl
干预措施: Fentanyl (Drug)
Group III
Pregnant with BMI>30 and having spinal anesthesia with 10 mg hyperbaric bupivacaine
干预措施: Bupivacaine (Drug)
Group IV
Pregnant with BMI>30 and having spinal anesthesia with 7,5 mg hyperbaric bupivacaine+25 mcg fentanyl
干预措施: Fentanyl (Drug)
结局指标
主要结局
VAS score < 6 with only spinal anesthesia
时间窗: Approximately 30 min, during surgery
Achieving surgical anesthesia with low dose spinal anesthesia in obese pregnants
次要结局
- Maternal hypotension(Approximately 30 min, during surgery)
研究者
CIGDEM YILDIRIM GUCLU
MD
Ankara University
