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临床试验/NCT05314257
NCT05314257Unknown2 期

Role of Granisetron in Preventing Hypotension After Spinal Anesthesia With Levobupivacaine in Rheumatic Patients Undergoing Elective Cesarean Section: A Randomized Clinical Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2022年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
102
试验地点
1
主要终点
post-spinal hypotension, and bradycardia

研究概览

简要总结

Cardiac disease in pregnancy is a high-risk condition and a major cause of maternal mortality and morbidity. Although direct or immediate death due to cardiovascular disease is rare, it is an important indirect cause of maternal death worldwide, with an attributable rate of two deaths per 100,000 pregnancies. Cardiovascular physiological changes during pregnancy impose an additional load on the cardiovascular system of women with underlying heart disease which increases morbidity and mortality during pregnancy and at the time of delivery. Among cardiac diseases, Rheumatic Heart Disease is the commonest cardiac disease complicating pregnancy.

详细描述

The subarachnoid block is the most used anesthesia technique for conducting a cesarean section. The incidence of hypotension following this procedure is as high as 20-40% in pregnant patients. Similarly, bradycardia is also commonly associated with post-SAB, and the reported incidence is around 13%. Spinal anesthesia results in sympathetic block leading to a decrease in systemic vascular resistance and hypotension. Hypotension caused by subarachnoid block is physiologically compensated by an increase in heart rate. However, if vagus nerve-mediated Bezold-Jarisch reflex gets stimulated, then the cardiac autonomic balance gets shifted towards the parasympathetic nervous system leading to bradycardia, which further precipitates hypotension.

Levobupivacaine is a highly potent long-acting local anesthetic with a comparatively slow onset of action. Compared to bupivacaine, it has a lower tendency to block deactivated cardiac sodium and potassium channels with a more rapid rate of dissociation. It has reduced cardiac toxicity on overdose intravenous administration due to its faster protein binding rate. Plain levobupivacaine is isobaric to CSF. One of its advantages is that it has a more expectable spread. Several studies have revealed the reduced occurrence of various side effects (such as nausea, vomiting, bradycardia, and hypotension) when levobupivacaine compared with bupivacaine for spinal anesthesia used for cesarean delivery. It has been suggested to use 12.5-13.5mg levobupivacaine for effective 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
Prevention
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

入选标准

  • Rheumatic female patients in the childbearing period scheduled for elective cesarean sections

排除标准

  • Patients with eclampsia and pre-eclampsia history,
  • uncontrolled diabetes mellitus, morbid obesity,
  • coagulation abnormalities,
  • vertebral deformities, also patients who refused regional anesthesia,
  • having contraindications to spinal anesthesia

研究组 & 干预措施

Group G

Active Comparator

IV granisetron 1mg

干预措施: Granisetron Hydrochloride (Drug)

Group C

Placebo Comparator

IV 5ml of 0.9% normal saline

干预措施: 0.9% normal saline (Other)

结局指标

主要结局

post-spinal hypotension, and bradycardia

时间窗: 24 hours postoperative

post-spinal hypotension, and bradycardia in rheumatic patients undergoing elective cesarean section

次要结局

未报告次要终点

研究者

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

Ghada Mohammed AboelFadl

Principal investigator

Assiut University

研究点 (1)

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