Prospective, Observational and Bicentric Study of the Management of Arterial Hypotension During Planned Caesarean Section. Practice Comparison Between a Referral Center Using According to Service Protocol, an Intravenous Ephedrine/Phenylephrine Mixture at the PSE Versus Another Referral Center Using According to Service Protocol Intravenous Baby Noradrenaline
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Systolic blood pressure
研究概览
简要总结
Comparison of two practices of obstetrical services between the CHU of Clermont Ferrand and the HFME Lyon-Bron in the management of arterial hypotension during an elective cesarean section
详细描述
The investigators propose to carry out a bicentric strict observational prospective study between the maternity of the HFME of Lyon-Bron which uses the mixture ephedrine / noradrenaline with the PSE for many years in service protocol for the management of hypotension for cesarean section under perimedullary anesthesia and the CHU of Clermont-Ferrand which uses baby noradrenaline 10 mcg/mL PSE for this same indication according to an institutional protocol. Patients corresponding to the inclusion and non-inclusion criteria will be recruited by a physician investigator and will give their agreement of non-opposition after having received clear oral and written information about our study. The care will not be modified in any way compared to the usual practices of the service.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •elective caesarean
- •≥ 18 years old
- •term ≥ 36 weeks amenorrhea
排除标准
- •contraindication of local anesthetics
- •contraindication of spinal anesthesia
- •patient's refusal
- •patient doesn't talk French
- •patient not covered by the social security system
结局指标
主要结局
Systolic blood pressure
时间窗: duration of the procedure up to one hour
Time-weighted mean intraoperative systolic blood pressure below a threshold of 80mmHg, 90mmHg and 100mmHg. This measurement is commonly called TWA (time weighted average), corresponding to the area between the chosen PAS threshold and the curve of the measured PAS, divided by the total time of the measurements. Blood pressure will be measured by the Clearsight system, absolutely non-invasive continuous pulse wave contour monitoring.
次要结局
- Clinical sign of hypotension(duration of the procedure up to one hour)
- crystalloids(duration of the procedure up to one hour)
- Foetal pH(at birth)
- total diuresis(duration of the procedure up to one hour)
- boli of vasopressor(duration of the procedure up to one hour)
- boli of atropine(duration of the procedure up to one hour)
- intrathecal local anesthetics(duration of the procedure up to one hour)