Randomized, Double-blind, Controlled Clinical Trial for Comparison of Continuous Phenylephrine Versus Norepinephrine Infusion for Maintenance of Hemodynamic Stability During Cesarean Section Under Spinal Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Cardiac output maintenance (measured in L/min by bioreactance).
研究概览
简要总结
Comparison between prophylactic continuous variable infusion of phenylephrine (starting dose 0,5mcg/kg/min) and norepinephrine tartrate (starting dose 0,1mcg/kg/min) to prevent hypotension and maintain cardiac output under spinal anesthesia during cesarean delivery.
详细描述
Maternal hypotension is a frequent complication after spinal anesthesia for cesarean delivery. Many vasopressors have been studied and used, but the perfect vasopressor is yet to be found. Phenylephrine is the most common used in obstetric anesthesia but its cardiac depressant activity, being an only alpha-adrenergic agonistic, is linked to frequent side effects such as bradycardia and decreased cardiac output.
Norepinephrine is a vasopressor characterized by both alpha and minor beta-adrenergic agonistic activity, it has then a minimal cardiac depressant activity. Hence it would provide a better stability of hemodynamic and cardiac output, and appears as a better alternative to phenylephrine.
In this study, the investigators will compare prophylactic continuous variable infusion of both vasopressors. Phenylephrine started at the dose of 0,5mcg/kg/min and Norepinephrine tartrate started at the dose of 0,1mcg/kg/min. The doses will be adjusted according to maternal systolic blood pressure in order to prevent hypotension (defined by a systolic blood pressure under 80% of baseline).
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
- Quadruple (Participant, 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
- 否
入选标准
- •Pregnancy higher than 36 weeks of amenorrhea
- •Scheduled or semi-urgent (interval between decision and delivery by cesarean section higher than 12hours) cesarean section under spinal anesthesia
排除标准
- •Extreme height (less than 140cm; higher than 180cm)
- •Weight less than 50kg
- •Weight higher than 120kg
- •Cardiovascular disease with use of cardiac medication (including antihypertensive drug)
- •Active neurological disease
- •Anti-hypertension treatment.
- •High blood pressure or severe pre-eclampsia
- •American Society of Anesthesiologists physical status class higher than 3
- •Placenta accrete/percreta
- •Cesarean section scheduled under general anesthesia
- •Contraindications to spinal anesthesia
- •Minor (age less than 18 years old)
- •Guardianship/ curatorship
- •Anemia less than or equal to 8 g/dl
- •Allergy to any study medication
- •Simultaneous participation in another study
研究组 & 干预措施
phenylephrine
Spinal anesthesia with bupivacaine, sufentanil and morphine will be performed and prophylactic infusion of phenylephrine started at an initial rate of 0,5mcg/kg/ min. The rate will be adjusted according to maternal systolic blood pressure.
干预措施: Phenylephrine (Drug)
Norepinephrine
Spinal anesthesia with bupivacaine, sufentanil and morphine will be performed and prophylactic infusion of norepinephrine tartrate started at an initial rate of 0,1mcg/kg/min. The rate will be adjusted according to maternal systolic blood pressure.
干预措施: Norepinephrine (Drug)
结局指标
主要结局
Cardiac output maintenance (measured in L/min by bioreactance).
时间窗: 5 minutes before the induction of spinal anesthesia until umbilical cord clamping.
Cardiac output values were analyses at eight points * Baseline measurement: patient placed in the supine position with the table tilted 10° left, before spinal anesthesia * Seven measurements at regular intervals: first measurement just after administration of spinal anesthesia in supine position with the table tilted 10° left and last measurement at umbilical cord clamping.
次要结局
- Systolic blood pressure(From induction of spinal anesthesia until weaning of vasopressor)
- Mean blood pressure(From induction of spinal anesthesia until weaning of vasopressor)
- Cardiac Output(after applying spinal anesthesia until weaning of vasopressor)
- Fetal lactates(At time of birth)
- Heart rate(From induction of spinal anesthesia until weaning of vasopressor)
- Duration of bradycardia(From induction of spinal anesthesia until weaning of vasopressor])
- Duration of hypotension with Mean blood pressure less than 65mmHg(after applying spinal anesthesia until weaning of vasopressor)
- Stroke Volume(after applying spinal anesthesia until weaning of vasopressor)
- Total dose of study drug consumed(after applying spinal anesthesia until weaning of vasopressor)
- Incidence of nausea or vomiting(after applying spinal anesthesia until weaning of vasopressor)
- APGAR score(10 minutes after delivery)
- Umbilical arterial partial pressure of oxygen(At time of birth)
- Duration of hypotension with Systolic Blood Pressure less than 80mmHg(after applying spinal anesthesia until weaning of vasopressor)
- Duration of hypertension(after applying spinal anesthesia until weaning of vasopressor)
- Total Peripheral Resistance(after applying spinal anesthesia until weaning of vasopressor)
- Total Rescue Bolus Dose of atropine to maintain Systolic Blood Pressure(after applying spinal anesthesia until weaning of vasopressor)
- Umbilical arterial base excess(At time of birth)
- Maximum flow rate of study drug given(after applying spinal anesthesia until weaning of vasopressor)
- Total Rescue Bolus Dose of ephedrine or other vasopressor to maintain Systolic Blood Pressure(after applying spinal anesthesia until weaning of vasopressor)
- Maternal blood glucose concentration(at umbilical cord clamping)
- Umbilical arterial partial pressure of carbon dioxide(At time of birth)
- Fetal blood glucose concentration at birth(At time of birth)
- Neonatal blood glucose concentration(at 1 hour after birth)
- Uterine and umbilical arteries Doppler with measurement of the pulsatility(5 minutes after induction of spinal anesthesia)
- Incidence of dizziness or malaise(after applying spinal anesthesia until weaning of vasopressor)
- Umbilical arterial potential hydrogen(At time of birth)