Impact of Preoperative Oral Rehydration on the Incidence of Spinal Anesthesia-induced Hypotension for Scheduled Cesarean Section.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Hypotension reduction
研究概览
简要总结
Study of the impact of preoperative oral rehydration on the incidence of spinal anesthesia-induced hypotension for scheduled cesarean section.
详细描述
What is already known ? Arterial hypotension is one of the most common complications following spinal anesthesia (60%). Several measures have been studied to prevent this hypotension, such as intravenous vascular filling (preloading, coloading), using different filling fluids (colloids vs crystalloids), preventive administration of vasopressors, reduction of doses and volumes administered in spinal anesthesia.
Only one study has evaluated the impact of oral rehydration on hypotension after spinal anesthesia.
Hypothesis:
The investigatord wish to demonstrate that an oral rehydration 2 hours before surgery, reduces by 50% the incidence of hypotension and / or the use of vasopressors, after spinal anesthesia
Primary outcome:
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients ≥ 18 years old
- •Scheduled for a scheduled cesarean, under spinal anesthesia (CSE)
- •Signature of informed consent
- •Single pregnancy of ≥ 36 weeks
- •150 cm <height <180 cm
- •50 kg <weight <100 kg
排除标准
- •Patient's refusal
- •Contraindication to spinal anesthesia
- •Allergy to a product used for anesthesia
- •Age < 18
- •Known or pregnancy-related hypertension
- •Gestational diabetes with insulin or pre-existing diabetes with insulin
- •Total language barrier without possibility of translation
结局指标
主要结局
Hypotension reduction
时间窗: 60 minutes
We aim for a 50% reduction in the incidence of hypotension following spinal anesthesia for scheduled C-section.
次要结局
- N+/V+(60 minutes)
- Umbilical pH(60 minutes)
研究者
Denis SCHMARTZ
Head of department, anesthesiology
Brugmann University Hospital