Special Maternal Care Bundle to Attenuate Spinal Induced Hypotension in Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- consumption of ephedrine
研究概览
简要总结
Cesarean Section (CS) is a common obstetric surgery that can be performed by both general or regional anaesthetic techniques. Hypotension is the most common complication of spinal anaesthesia, its incidence varying from 70% to 80 %, if severe, it can result in serious perinatal adverse outcomes, such as maternal nausea and vomiting, fetal acidosis and may be an important contributory factor for maternal death related to regional anaesthesia.
详细描述
A variety of methods have been used for the prevention of post-spinal hypotension which includes the use of intravenous fluid, vasopressors, and physical methods such as table tilt, leg binders, and compression devices. However, a single technique is ineffective and a combination of interventions is suggested.
A care bundle is a group of three to five evidence-based interventions that, when performed together, have a better outcome than if performed individually. A care bundle consists of a group of (usually) between three and five evidence-based interventions. These are related to a particular condition or event for patient care.
Care bundles are well known in the field of intensive care medicine such as Ventilator-Associated Pneumonia (VAP) care bundle, sepsis care bundle, and Central Line-Associated Bloodstream Infection (CLABSI) care bundle.
To our knowledge, till now, no one has investigated a special care bundle in the field of anaesthesia.
In this work, we will investigate the safety and efficacy of a special care bundle in controlling spinal induced hypotension.
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)
盲法说明
patients will be randomly allocated by a computer software program (www. Randmizer.org) and allocation sequence will be done by opaque closed envelope.
Data will be collected by a separate anesthesiologist not sharing in the study and blinded to the technique being used.
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age more than 21 years old and less than 40 years.
- •Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status Grade II) = (patients with mild systemic disease and no functional limitations).
- •None laboring, at term with singleton uncomplicated pregnancies.
- •Delivery under spinal anesthesia, with height 150 to 180 cm
- •Body mass index of at most 40 kg/m2.
排除标准
- •Parturient with peri-partum disorders as DM, HTN, cardiac diseases, bronchial asthma or bleeding disorders
- •Obesity: BMI >40
- •Any known allergy to local anesthetic drugs or ondansetron.
- •Apparent anatomical abnormalities or infections in the back region.
- •Bleeding disorders e.g., thrombocytopenia, high INR, high PT in the chronic liver or impaired kidney).
- •Refusal to participate in the study
结局指标
主要结局
consumption of ephedrine
时间窗: immediately at the end of the surgery
The total consumption of ephedrine used to manage the spinal induced hypotension with CS
次要结局
- postspinal hypotension(immediately at the end of the surgery)
- consumption of atropine(immediately at the end of the surgery)
研究者
Abdelrhman Alshawadfy
Lecturer of anesthesia and intensive care
Suez Canal University