Effect of Maternal Body Mass Index on the Prophylactic Dose of Norepinephrine Infusion for Preventing Hypotension in Parturient After Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of hypotension after spinal anesthesia
研究概览
简要总结
This is a randomized, double-blinded controlled study that aims to estimate the effect of maternal body mass index on the prophylactic dose of norepinephrine infusion for preventing hypotension in parturient after spinal anesthesia.
详细描述
This is a randomized, double-blinded controlled study that aims to estimate the effect of maternal body mass index on the prophylactic dose of norepinephrine infusion for preventing hypotension in parturient after spinal anesthesia.
Routine preoperative investigations will be done to all patients including laboratory investigations as (complete blood picture, prothrombin time and partial thromboplastin time), age and BMI will be recorded.
All the patients will be fasting for solid food for 6-8 hours and for clear fluids for 4 hours before surgery.
Upon entry into the operating theater, all patients will be placed under standard American Society of Anesthesiologist (ASA) monitoring including 5-lead electrocardiography, pulse oximetry and non-invasive blood pressure. Baseline values of systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and mean blood pressure (MBP) will be measured in supine position with left uterine displacement (15 degree wedge under the right buttock) and recorded as the arithmetic mean of three consecutive measurements at least 2 min intervals with a difference of less than 10%.
As per standard practice, SBP, DBP, MBP, HR and pulse oximetry measurements will be recorded in every 2 min throughout the surgery. An 18-gauge cannula will be inserted into a large vein, The patients will receive no premedication. The study period will be the interval between the initiation of spinal injection and delivery of the fetus .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A normal singleton pregnancy with a gestational age of ≥ 37 weeks. 18-40 years old pregnant women scheduled for elective C/S under spinal anesthesia.
排除标准
- •Any absolute contraindication to spinal block, Neurological or cardiac disorder, Basal systolic blood pressure above 140 mmHg or below 100 mmHg, Peripartum bleeding or emergent situations both for fetus and mother, Those who refused to participate in the study were excluded Known fetal abnormality, intrauterine growth restriction, Obstetric complication (ruptured membranes, placenta previa, placental abruption),
结局指标
主要结局
Incidence of hypotension after spinal anesthesia
时间窗: From spinal anesthesia until delivery of the fetus.
Hypotension defined as a ≥20% decrease in systolic blood pressure from baseline.
次要结局
- Bradycardia(From spinal anesthesia until the end of surgery.)
- Reactive hypertension(From spinal anesthesia until the end of surgery.)
- Nausea and vomiting(From spinal anesthesia until the end of surgery.)
- Apgar score at 1 minute(1 minute after delivery.)
- Apgar score at 5 minutes(5 minutes after delivery.)
- Number of rescue interventions(From spinal anesthesia until the patient leaves the operating room.)