Efficacy and Safety of Prophylactic Norepinephrine Addition in Prevention of Hypotension During Spinal Anesthesia for Caesarean Delivery: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of hypotension
研究概览
简要总结
The objective is to compare efficacy of prophylactic norepinephrine bolus versus Infusion in prevention of hypotension which occurs frequently after spinal anesthesia for caesarean section. The authors hypothesize that prophylactic norepinephrine bolus is as effective as infusion in Prevention of hypotension after spinal anesthesia in caesarean section
详细描述
Introduction Spinal anesthesia is the technique of choice for elective cesarean delivery. During spinal anesthesia for cesarean delivery, maternal hypotension is a major complication with the incidence up to 60-70%. Prolonged hypotension leads to decreased utero-placental blood flow and fetal acidosis. Vasopressors such as ephedrine, phenylephrine, and norepinephrine are therefore commonly recommended to reduce the incidence of hypotension.Phenylephrine is currently the first-choice vasopressor for prevention and treatment of maternal hypotension during spinal anesthesia for cesarean delivery (CD).
phenylephrine in this context has been questioned, owing to its propensity to increase afterload, reduce maternal heart rate, and reduce cardiac output. A recent studies indicated that norepinephrine infusion or bolus during spinal anesthesia for cesarean delivery was associated with greater heart rate and cardiac output compared with phenylephrine. Other studies also showed that norepinephrine could act as an alternative to phenylephrine without adverse outcomes.Because it is a potent α-adrenergic agonist with some β-adrenergic effect and, therefore, should not have a tendency to reduce heart rate and cardiac output as much as phenylephrine.
The use of norepinephrine to prevent and treat hypotension during CD is new and data in the literature are scarce. Although treatment of hypotension during spinal anesthesia is listed by the manufacturer as an indication for the use of norepinephrine, there is limited information available for its use for this purpose in the literature and few reports of its use in obstetric patients.
Carvalho and Dyer suggested that more investigations of norepinephrine using simpler methods of delivery than computer-controlled systems are required. Such studies are now emerging.
Anesthetic technique:
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 (Participant, Care Provider, Investigator)
盲法说明
An anesthesia resident who will not be involved with the conduct of the study will prepare and label the drug in the syringes according to the randomization codes.
An investigator who will not be involved in subsequent patient care or assessment will open the topmost of 300 opaque sequentially numbered envelopes. One 50 ml and one 10 ml will be labeled as study drug and the 50 ml syringe will be connected to a syringe infusion pump. These two "study drug" syringes will be a part of double dummy technique to facilitate blindness. In group B, 50 ml syringe will contain saline, and 10 ml syringe will contain norepinephrine (.6 µg/ml). In group I, 50 ml syringe will contain norepinephrine (6 µg/ml) with, and 10 ml syringe will contain saline. Participant in both groups will receive bolus from 10 ml syringe over 30 seconds and infusion dose of 1 ml/kg/h simultaneously to expedite blinding.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 - 45 years
- •American Society of Anesthesiologists physical status classification II or III
- •Elective caesarean section under spinal anesthesia
- •Normal singleton pregnancy beyond 36 weeks gestation
- •Weight 50-100 kg, height 150-180 cm
排除标准
- •Patient refusal
- •Allergy or hypersensitivity to norepinephrine
- •Diabetes, excluding gestational diabetes
- •Preexisting or pregnancy-induced hypertension
- •Arrhythmia
- •Cerebrovascular disease
- •Known fetal abnormality or fetal distress
- •Any contraindication to spinal anesthesia
- •Use of monoamine oxidase inhibitors, triptyline or imipramine antidepressants
研究组 & 干预措施
group B
'Norepinephrine bolus' of 6 µg plus Normal Saline 0.9% Infusion Solution
干预措施: Norepinephrine Bolus (Drug)
group B
'Norepinephrine bolus' of 6 µg plus Normal Saline 0.9% Infusion Solution
干预措施: Normal Saline 0.9% Infusion Solution (Drug)
group I
'Norepinephrine infusion' 6 µg/kg/h plus 'Normal Saline Flush, 0.9% Injectable Solution
干预措施: Norepinephrine infusion (Drug)
group I
'Norepinephrine infusion' 6 µg/kg/h plus 'Normal Saline Flush, 0.9% Injectable Solution
干预措施: Normal Saline Flush, 0.9% Injectable Solution (Drug)
结局指标
主要结局
Incidence of hypotension
时间窗: 5 to 15 minutes after giving spinal anesthesia
less than 80% baseline blood pressure
次要结局
- Presence of vomiting(30 minutes)
- Presence of Nausea(30 minutes)
- Umbilical vein pH(1 minute after delivery)
- Baseline heart rate(3 minutes before giving spinal anesthesia)
- Baseline mean blood pressure(3 minutes before giving spinal anesthesia)
- Baseline systolic blood pressure(3 minutes before giving spinal anesthesia)
- Anesthesia to delivery time(from immediately after giving anesthesia until delivery of fetus by surgeon)
- Incision to delivery time(in time of beginning of surgical incision of skin until delivery of fetus by surgeon)
- Uterine incision to delivery time(in time of beginning of uterine incision until delivery of fetus by surgeon)
- Upper sensory level of anesthetic block(3 minutes after giving spinal anesthesia)
- Incidence of hypertension(30 minutes)
- Occurence of bradycardia(30 minutes)
- Occurence of tachycardia(30 minutes)
- Umbilical artery pH(1 minute after delivery)
- Umbilical artery partial pressure of carbon dioxide(1 minute after delivery)
- Umbilical vein partial pressure of carbon dioxide(1 minute after delivery)
- Umbilical artery partial pressure of oxygen(1 minute after delivery)
- Umbilical vein partial pressure of oxygen(1 minute after delivery)
- Umbilical artery bicarbonate(1 minute after delivery)
- Umbilical artery base excess(1 minute after delivery)
- Umbilical vein bicarbonate(1 minute after delivery)
- Umbilical vein base excess(1 minute after delivery)
- APGAR score(5 minutes after delivery)
- Rescue ephedrine dose(every 2 minutes up to 30 minutes immediately after occurence of hypotension)
- first rescue ephedrine dose time(1 minute after giving rescue ephedrine)
- Total used ephedrine dose(1 minute after correction of blood pressure)
研究者
Yasser S Mostafa, MD
Lecturer of anesthesia
Fayoum University Hospital