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临床试验/NCT04951167
NCT04951167Unknown不适用

EFFECT OF DIFFERENT NOREPINPHRINE APPLICATION METHODS IN CAESARIANES ON HYPOTENSION AFTER SPINAL ANESTHESIA

Inonu University1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2021年5月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
208
试验地点
1
主要终点
systolic blood pressure

研究概览

简要总结

There are previous studies in which norepinephrine was administered only as a prophylactic or only infusion to prevent hypotension after spinal anesthesia in cesarean sections. However, there are not enough studies reporting which of these application methods are more effective. Therefore, in our study, cesarean section under spinal anesthesia was planned; We aimed to investigate the effectiveness of norepinephrine differential administration methods on preventing maternal hypotension.

详细描述

EFFECT OF DIFFERENT NOREPINPHRINE APPLICATION METHODS IN CAESARIANES ON HYPOTENSION AFTER SPINAL ANESTHESIA INTRODUCTION Spinal anesthesia in cesarean sections is a frequently used anesthesia technique today. The most common complication associated with spinal anesthesia is hypotension. Systemic vascular resistance and cardiac output decrease due to sympathetic blockade, and when this is accompanied by bradycardia and contractility, hypotension develops(1,2,3).

Maternal hypotension is a condition that can cause negative consequences such as nausea, vomiting, and dizziness in pregnant women who undergo spinal anesthesia. In addition, it increases the likelihood of fetal acidosis, hypoxia, and neonatal neurological damage. Therefore, it is necessary to treat maternal hypotension effectively. In the current treatment of maternal hypotension, intravenous fluid administration, treatments such as ephedrine, phenylephrine, and norepinephrine are used (4,5,7). Among these drugs, ephedrine is the first preferred vasopressor (4). For this reason, its efficacy and safety, and the use of different doses have been extensively studied (5,7). Ephedrine is a vasopressor with both direct and indirect effects in the treatment of hypotension due to neuraxial block in obstetrics with its alpha and beta agonist effects. The most important disadvantage of ephedrine is that it has a slow onset and weak effect, difficulty in titration, development of tachyphylaxis, causing maternal tachy-arrhythmias and fetal acidosis (9). Ephedrine easily crosses the placenta and causes fetal tachycardia, an increase in noradrenaline concentration in the umbilical artery (UA), and a decrease in pH and base excess (BE). An increase in fetal metabolic rate, an increase in fetal O2 consumption and CO2 production, and an increase in lactate level are observed through beta-adrenergic stimulation (9). Phenylephrine, on the other hand, is a pure alpha-agonist agent that is more potent (phenylephrine/ephedrine: 80:1), easy to titrate, effectively treats hypotension and nausea-vomiting, has minimal placental transfer, and does not cause fetal acidosis and changes (10-11). However, the disadvantage of phenylephrine is that it decreases maternal heart rate and cardiac output (12). Another vasopressor drug used in the treatment of hypotension in recent years is norepinephrine. Norepinephrine is both an α-receptor agonist and a weak β-receptor agonist (7,8). Theoretically, it lowers heart rate and cardiac output less.

There are previous studies in which norepinephrine was administered only as a prophylactic or only infusion to prevent hypotension after spinal anesthesia in cesarean sections. However, there are not enough studies reporting which of these application methods are more effective. Therefore, in our study, cesarean section under spinal anesthesia was planned; We aimed to investigate the effectiveness of norepinephrine differential administration methods on preventing maternal hypotension.

WORKING PROTOCOL After the approval of the faculty ethics committee, the written and verbal consent of the patients will be obtained, and a double-blind randomized study will be initiated.

Pregnant women over the age of 18, with ASA (American Society of Anesthesiologists physical status) ≤ III, body weight 50-100 kg and height 150-180 cm, with a single pregnancy planned for cesarean section under elective conditions under spinal anesthesia, will be included in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Pregnant women will be randomly divided into 4 groups using the closed envelope method. The person who prepares the study drugs and follows the study will be different and unaware of the study.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women over the age of 18, with ASA (American Society of Anesthesiologists physical status) ≤ III, body weight 50-100 kg and height 150-180 cm, with a single pregnancy planned for cesarean section under elective conditions under spinal anesthesia, will be included in the study.

排除标准

  • Pregnant women with allergy or hypersensitivity to norepinephrine, pre-existing hypertension or pregnancy-induced hypertension, cardiovascular or cerebrovascular disease, renal failure, history of thrombosis in the mesenteric or peripheral vessels, history of diabetes with known fetal anomalies, users of monoaminooxidase inhibitors, tricyclic antidepressants and those who refused to study were excluded.

研究组 & 干预措施

PB: prophylactic bolus

Active Comparator

an IV bolus of 4 mcg Norepinephrine will be administered immediately after spinal anesthesia, and then SF infusion will be started at 1 ml/min.

干预措施: Norepinephrine (Drug)

PI:prophylactic infusion

Active Comparator

1ml of saline is administered immediately after spinal anesthesia, and then infusion will be started with the study drug at 1 ml/min.(4mcg/min)

干预措施: Norepinephrine (Drug)

TB:therapeutic bolus

Active Comparator

immediately after spinal anesthesia, 1 ml of saline, followed by 1 ml/min infusion of SF, and when the blood pressure decreases by 20%, 1 ml of working solution and then 1 ml/min of saline infusion will be started.

干预措施: Norepinephrine (Drug)

TBI:therapeutic bolus-infusion

Active Comparator

1 ml of study drug and 1 ml/min of study drug infusion will be started immediately after spinal anesthesia, after 1 ml of saline followed by 1 ml/min of SF infusion when blood pressure decreases by 20% of the entry

干预措施: Norepinephrine (Drug)

结局指标

主要结局

systolic blood pressure

时间窗: every 2 mins from intrathecal drug administration until delivery

When systolic blood pressure drops more than 20% compared to baseline, it will be considered as hypotension

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nurşen Seyhun

M.D.

Inonu University

研究点 (1)

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