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临床试验/NCT05658380
NCT05658380已完成3 期

Impact of Pre-spinal Atropine on Post Spinal Hemodynamics and Cardiac Output Measured by Electrical Cardiometry in Caesarean Delivery: Randomized Double Blinded Controlled Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年12月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
1
主要终点
change in cardiac output measurment

研究概览

简要总结

Cesarean section is one of the most commonly performed surgical procedures; approximately 80-90% of elective cesarean sections are conducted using spinal anesthesia . Spinal anesthesia is the preferred technique for Cesarean Section (CS) due to its simplicity, reliability, low rates of airway complications, facilitation of postoperative analgesia, less neonatal exposure to potentially depressant drugs, to awake mother at the time of the birth of the child that establishes maternal-infant bonding and successful breastfeeding, and due to its low cost as compared to the general anesthesia . The chance of significant maternal hypotension is greater with spinal anesthesia than with epidural anesthesia. Left uterine displacement with appropriate administration of fluids and use of vasopressor medications can minimize the associated hypotension. Intravenous administration of crystalloid or colloid can reduce the degree of hypotension after spinal anesthesia for cesarean delivery.

Maternal hypotension is a frequent side effect of spinal anesthesia for cesarean delivery and it causes dangerous maternal and fetal effects . Maternal hypotension decreases uteroplacental circulation and it results in nausea, vomiting, bradycardia and different systems dysfunction particularly in the presence of other diseases as renal, hepatic, cardiac and neurological. Anesthesiologists should not allow hypotension to continue, this often requires the use of vasopressors to maintain blood pressure as ephedrine, phenylephrine and norepinephrine .

Cardiac output is the amount of blood pumped by the heart per unit of time and is determined by four factors: two factors that are intrinsic to the heart-heart rate and myocardial contractility-and two factors that are extrinsic to the heart -preload and afterload. Heart rate is defined as the number of beats per minute and is mainly influenced by the autonomic nervous system. Increases in heart rate escalate cardiac output if ventricular filling is adequate during diastole .

Atropine is an anticholinergic agent with its ability to treat bradycardia both in mother and fetus. Atropine is an anti-sialagogue as well as used to antagonize the muscarinic side effects of anticholinesterases. Atropine is detected in the umbilical circulation within 1 to 2 minutes of maternal administration, and an F/M ratio of 0.93 is attained at 5 minutes .

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • American society of anaesthesiologists (ASA) II
  • full term
  • singleton
  • pregnant women scheduled for elective Cs

排除标准

  • patients refusal
  • with body mass index (BMI) > 35 Kg/m2
  • polyhydramnios
  • history of impaired cardiac contractility
  • valvular heart disease
  • cardiac arrhythmias
  • hypertensive pregnancy disorders
  • thyrotoxicosis
  • cerebrovascular diseases
  • foetal abnormalities
  • Contraindications to spinal anesthesia as coagulopathy, infection at the site of needle insertion
  • uncorrected hypovolemic shock
  • increased intracranial pressure from mass effect
  • inadequate resources or expertise.

研究组 & 干预措施

atropine

Active Comparator

干预措施: atropine (Drug)

normal saline

Placebo Comparator

干预措施: Isotonic saline (Drug)

结局指标

主要结局

change in cardiac output measurment

时间窗: basline and 5 minute after spinal anesthesia

change in cardiac output (CO) will be measured by electrical cardiometry

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

Amin Mohammed Alansary Amin Ahmed Helwa

Assistant professor

Ain Shams University

研究点 (1)

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