Randomized Double-blinded Comparison of Norepinephrine and Phenylephrine in Bolus for Maintenance of Blood Pressure During Spinal Anesthesia for Cesarean Delivery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
This study evaluate the ability of phenylephrine and of noradrenaline to maintain normal systemic arterial blood pressure and heart rate in healthy pregnant women submitted to cesarean section with spinal anesthesia. Half of participants will receive bolus of phenylephrine while the other half will receive bolus of noradrenaline.
详细描述
This is a prospective, randomized, double-blind, comparative two-group clinical study to observe two vasopressor drugs, phenylephrine and noradrenaline, in the ability to maintain systemic arterial pressure in pregnant women after spinal anesthesia for cesarean section; based on the hypothesis that, since noradrenaline has a predominant alpha-adrenergic action and a weak 1- beta-adrenergic beta action, it could be as capable of maintaining blood pressure effectively as phenylephrine, but with a lower frequency of bradycardia; patients who meet the inclusion criteria will be randomly assigned to one of the groups to be studied: group F - phenylephrine at a dose of 100mcg bolus and N - noradrenaline at the dose of 5mcg. One of these drugs will be used whenever systolic blood pressure drops below 10% of the baseline, additional doses will be allowed whenever necessary, aiming at maintaining the systolic blood pressure at baseline values; the blood pressure will be measured non-invasively and the heart rate by pulse oximeter and electrocardiogram.
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, Care Provider, Investigator)
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
- •Pregnant women, with single gestation, with cesarean programming to be performed under spinal anesthesia;
- •Age above 18 years;
- •Physical State American Society of Anesthesiologists (ASA) II and III;
- •Weight between 50kg and 120kg;
- •Height between 140cm and 180cm.
排除标准
- •Refusal to participate in the study;
- •Pregnant women with fetus with known abnormalities;
- •Pregnant women with cardiovascular disease;
- •Pregnant women with pregnancy-specific hypertensive disease;
- •Allergy to any medication to be used in the study;
- •Users of monoamine oxidase inhibitors;
- •Users of tricyclic antidepressants;
- •Emergency caesarean section due to acute fetal distress;
- •Situations in which the sensory level after single intrathecal injection of the local anesthetic does not reach at least T6 within 5 minutes after spinal anesthesia.
研究组 & 干预措施
Phenylephrine 100 mcg
Phenylephrine will be used at a dose of 100 mcg bolus at a dilution containing 20 mcg / mL of the drug to be used whenever systolic blood pressure falls below 10% of baseline.
干预措施: Phenylephrine 100 mcg (Drug)
Norepinephrine 5 mcg
Norepinephrine will be used at a dose of 5 mcg at a dilution containing 1 mcg / mL to be used whenever systolic blood pressure falls below 10% of baseline.
干预措施: Norepinephrine 5 mcg (Drug)
结局指标
主要结局
Heart rate
时间窗: during the procedure
Number of episodes of heart rate under 60 bpm while using phenylephrine and noradrenaline in pregnant women undergoing spinal anesthesia for cesarean
Number of bolus required
时间窗: during the procedure
Number of bolus doses of phenylephrine and noradrenaline to maintain systemic arterial pressure at 90% of baseline in pregnant women undergoing spinal anesthesia for cesarean
次要结局
- Neonatal gasometric outcome(during the procedure)
- Neonatal Apgar outcome(during the procedure)
- Nausea and vomiting(during the procedure)
研究者
DANIEL VIEIRA DE QUEIROZ
Department Chair
Hospital dos Servidores do Estado do Rio de Janeiro