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临床试验/NCT06231316
NCT06231316尚未招募不适用

Preventing Spinal Hypotension During Cesarean Birth With Two Initial Boluses of Norepinephrine

Assiut University0 个研究点目标入组 100 人开始时间: 2024年3月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
The frequency of postspinal hypotension

研究概览

简要总结

Examining the advantages associated with the utilization of noradrenaline in preventing spinal hypotension during cesarean births. This involves assessing the positive outcomes and potential benefits derived from incorporating noradrenaline into the medical approach.

详细描述

Spinal anesthesia is used during cesarean section to provide rapid onset and dense block of motor and sensory nerves, intraoperative analgesia, and help patients remain conscious (1,2).Hypotension is common during induction of spinal anesthesia for cesarean delivery (CD) (3).If not promptly treated, a decrease in blood pressure (BP) can have deleterious effects, which include maternal nausea, vomiting, dizziness, and cardiovascular instability as well as decreased uteroplacental blood flow with resultant fetal acidosis, hypoxia, and bradycardia.In the last decade, the α-agonist phenylephrine (PE) has been the vasopressor of choice for the prevention and treatment of spinal induced hypotension (4).To prevent and treat postspinal anesthesia hypotension during cesarean section, vasopressors are recommended. Vasopressors (especially potent α-adrenergic receptor agonists) help offset the decrease in arteriolar dilation and peripheral vascular resistance caused by sympathetic nerve blockade after spinal anesthesia and may be associated with decreased incidence of neonatal acidosis.(5,6). Norepinephrine is another vasopressor that was recently introduced in obstetric anesthesia (7). Norepinephrine is characterized by α-adrenergic agonistic activity in addition to a weak β-adrenergic agonistic activity; thus, norepinephrine is considered a vasopressor with minimal cardiac depressant effect(7).; these pharmacologic properties would make norepinephrine an attractive alternative to phenylephrine and ephedrine in obstetric anesthesia. Although the use of norepinephrine for prophylaxis against postspinal hypotension has shown promising results,(7,8) evidence is lacking on the optimum dose for norepinephrine infusion during cesarean delivery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • The subject is scheduled for elective cesarean section .
  • No obvious abnormalities in preoperative ECG, blood routine, electrolytes, and other tests.
  • ASA class 1-3.

排除标准

  • Patients have body mass index (BMI) >35 kg/m
  • Patients are known hypersensitivity to any of the drugs that would be used in the study. -
  • Severe cardiac, renal, lung, or liver diseases.
  • Eclampsia or preexisting hypertension (baseline systolic blood pressure ≥160 mmHg)
  • hemoglobin <7 g/dL, or fetal distress.
  • Patients that are immunologically compromised.
  • Sleep apnea syndrome or difficult airway. 8.preexisting hypoxemia (Spo2< 90 %).
  • Patient refusal.

结局指标

主要结局

The frequency of postspinal hypotension

时间窗: baseline

Assessment of how often blood pressure decreases following spinal anesthesia, crucial for proactive management in medical procedures.

次要结局

  • Hemodynamic data(baseline)

研究者

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

Mohammad Mousa Abd Elsadek Ahmed

Doctor

Assiut University

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