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临床试验/NCT02862873
NCT02862873终止不适用

Iinterest of Intravenous Ondansetron in the Prevention of Spinal Anaesthesia-induced Hypotension in Caesarean Section: Double-blind Randomized Controlled Single-centre Study

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2015年3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
终止
入组人数
7
试验地点
1
主要终点
number of Systolic blood pressure below 90 mmHg

研究概览

简要总结

The intravenous injection of 8mg of ondansetron (a serotonin type 3 receptor antagonist) before spinal anaesthesia for caesarean section, leads to a smaller reduction in systolic arterial pressure (SAP).

The expected results are a decrease in the frequency and severity of hypotension, thus leading to improved comfort for the mother and decreased maternal and foetal morbidity. Indeed, episodes of hypotension are responsible for impaired foeto-placental circulation, with sometimes severe consequences for neonates.

It has been established that episodes of hypotension alter foetal pH. Investigators therefore hope to see a smaller reduction in SAP in the ondansetron group, and show a benefit for the infant.

One of the objectives of this study is also to observe a decrease in the quantity of vasopressors used and thus to avoid the adverse effects of their use in high doses.

The expected results are thus an improvement in haemodynamic stability during spinal anaesthesia for caesarean section.

The originality of this project lies in the use of a CNAP monitor (Continuous Non-invasive Arterial Pressure) as the collection of haemodynamic data will allow greater precision with the continuous measurement of AP, as well as a study of maternal cardiac output.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Persons who have provided written informed consent
  • Persons with national health insurance cover
  • Patients aged over 18 years, ASA I or II
  • About to undergo scheduled or non-scheduled caesarean section under spinal anaesthesia

排除标准

  • Adults under guardianship
  • Contra indication for spinal anaesthesia (SA) (refusal, haemodynamic instability, innate or acquired coagulation disorder)
  • History of hypersensitivity to Zophren or local anaesthetics
  • Heart and/or kidney failure
  • Treatment with angiotensin converting enzyme (ACE) inhibitor, Beta Blockers, or angiotensin II receptor antagonist (ARA II), Zophren, atropine, Selective Serotonin Reuptake Inhibitors, Triptans
  • Caesarean in a context of extreme emergency, with a time to foetal extraction incompatible with SA and the injection of Zophren, (up to 30 minutes) and requiring consent in an emergency.
  • Pregnancy-related arterial hypertension (AHT)
  • Pre-eclampsia
  • Gestational diabetes

研究组 & 干预措施

Ondansetron

Experimental

干预措施: Spinal anaesthesia (Procedure)

Ondansetron

Experimental

干预措施: Ondansetron (Drug)

Saline solution

Placebo Comparator

干预措施: Spinal anaesthesia (Procedure)

Saline solution

Placebo Comparator

干预措施: saline solution (Other)

结局指标

主要结局

number of Systolic blood pressure below 90 mmHg

时间窗: every 2 minutes from the intrathecal injection for 20 minutes, and then every 5 minutes until the end of the surgery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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