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临床试验/NCT04719819
NCT04719819已完成不适用

Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study

University Hospital, Clermont-Ferrand7 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2021年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
600
试验地点
7
主要终点
Maternal data

研究概览

简要总结

Most of caesarean sections can be performed under spinal anaesthesia. Its major advantages are reliability and fast onset. However, dose of hyperbaric bupivacaine used, combination with adjuvants, hemodynamic management, and impact of these measures on maternal experience are not uniform. This study aims to describe practices of spinal anaesthesia for caesarean section in France to improve practices, guide new studies and establish protocols.

详细描述

Most of caesarean sections can be performed under spinal anaesthesia. Its major advantages are reliability and fast onset. However, techniques of spinal anaesthesia are varied. Dose of hyperbaric bupivacaine used may shifted, varying intensity of sensor block but also hemodynamic side effect. Likewise, use of adjuvant is frequent and differs between centres. Management of the maternal hemodynamic is also discussed. While it is recognized that intraoperatively vascular filling alone is not effective, use of vasopressors is not unequivocal. For example, recent studies support the use of norepinephrine.

Finally, maternal experience is a hot topic. Although insufficient anaesthesia is rare, it is often overlooked. There are few recommendations on the intraoperative treatment of insufficient anaesthesia and to the management of post-traumatic stress that it lead to.

The objective of this study is to describe practices of spinal anaesthesia for scheduled or non-emergency caesarean section (also named "green code") in France by detailing several points:

Technique of spinal anaesthesia:

  • The anaesthesia solution used (doses and adjuvants)
  • Management of hemodynamic
  • Management of insufficient anaesthesia
  • Maternal experience It aims to make an inventory of practices, to orient future studies, guide practice and the realization of protocols.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age ≥ 18 years old
  • Affiliation to social security system
  • Scheduled or elective Caesarean section (green code) under spinal anesthesia

排除标准

  • Refusal to participate in the study
  • Code red Caesarean section or general anesthesia decision
  • Complicated" Caesarean section or combined spinal-epidural technique
  • Presence of an epidural catheter
  • Performing a combined spinal-epidural technique (even if the epidural catheter is not used)
  • Contraindication to spinal anaesthesia (coagulation disorder, vertebral-medullary pathologies)
  • Patient under guardianship or curatorship

结局指标

主要结局

Maternal data

时间窗: Day of surgery

Ad hoc Questionnaire

Obstetrical data

时间窗: Day of surgery

Ad hoc Questionnaire

Spinal procedure

时间窗: Day of surgery

Ad hoc Questionnaire

Haemodynamic management

时间窗: Day of surgery

Ad hoc Questionnaire

Maternal experience

时间窗: Day of surgery

Ad hoc Questionnaire

次要结局

未报告次要终点

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (7)

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