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临床试验/NCT02563795
NCT02563795已完成不适用

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?

Ankara University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

CIGDEM YILDIRIM GUCLU

MD

Ankara University

研究点 (1)

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