跳至主要内容
临床试验/NCT01841606
NCT01841606已完成2 期

The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries Under Spinal Anesthesia: A Randomized Controlled Trial

University of British Columbia1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
57
试验地点
1
主要终点
Change in Cardiac Output From Baseline to 20 Minutes Post-spinal

研究概览

简要总结

Ondansetron is a medication routinely given to mothers having cesarean deliveries to help prevent and treat nausea and vomiting. The investigators are studying the hemodynamic effects of prophylactic ondansetron on parturients undergoing elective cesarean deliveries under spinal anesthesia.

详细描述

Spinal anesthesia is a routine anesthetic technique for elective cesarean deliveries. Although this provides safe and effective surgical anesthesia, it is not without side effects, including both hypotension and bradycardia. The incidence of hypotension following spinal anesthesia has been estimated to be as high as 80% in an obstetric population. A number of factors are also likely involved in the development of hypotension and bradycardia, including the Bezold-Jarisch Reflex (BJR).

Two human studies with spinal anesthesia, one in an obstetric population, have demonstrated ondansetron's ability to presumably attenuate the BJR and better prevent hypotension by antagonism of 5-HT3 receptors. Maintenance of blood pressure and heart rate are vitally important, as they are required for adequate perfusion of the fetus prior to delivery.

The investigators plan to investigate the hemodynamic effects of prophylactic ondansetron on parturients undergoing elective cesarean deliveries under spinal anesthesia.

Ondansetron is classified as a Pregnancy Category B drug by the FDA, meaning that no adverse fetal effects have been demonstrated in animal studies, but that there is a lack of well controlled studies in pregnant humans.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Elective CD under spinal anesthesia
  • Fluency in English

排除标准

  • Contraindication to spinal anesthesiA
  • Allergy to ondansetron

研究组 & 干预措施

Ondansetron

Experimental

4mg of IV ondansetron 5 minutes prior to initiation of spinal anesthesia

干预措施: Ondansetron (Drug)

Placebo

Placebo Comparator

10mL of IV normal saline 5 minutes prior to initiation of spinal anesthesia

干预措施: Normal saline (Other)

结局指标

主要结局

Change in Cardiac Output From Baseline to 20 Minutes Post-spinal

时间窗: Baseline and 20 minutes

Maximum change in cardiac output from initiation of spinal anesthesia (baseline) until uterine incision (20 minutes post-spinal)

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

Vit Gunka

Principle Investigator

University of British Columbia

研究点 (1)

Loading locations...

相似试验