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临床试验/NCT03778723
NCT03778723已完成不适用

Cerebral Oxygenation and Metabolism in Patients Undergoing Clipping of Cerebral Aneurysm: A Comparative Study Between Propofol-based Total Intravenous Anesthesia and Sevoflurane-based Inhalational Anesthesia

Mansoura University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年12月18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
状态
已完成
入组人数
50
试验地点
1
主要终点
Arterio-Jugular oxygen content difference

研究概览

简要总结

Despite the theoretical benefits of i.v. agents, volatile agents remain popular. In a study comparing desflurane, isoflurane, and sevoflurane in a porcine model of intracranial hypertension, at equipotent doses and normocapnia, cerebral blood flow (CBF) and ICP were least with sevoflurane.

Propofol is the most commonly used intravenous anesthetic. It has many theoretical advantages by reducing cerebral blood volume (CBV) and ICP and preserving both autoregulation and vascular reactivity. Neurosurgical patients anaesthetized with propofol were found to have lower ICP and higher CPP than those anaesthetized with isoflurane or sevoflurane.

The well known pharmacodynamic advantages of intravenous anesthetics may give this group of drugs superior cerebral effects when compared with inhalation anesthetics.

详细描述

The aim of this study is to evaluate the cerebral hemodynamics and global cerebral oxygenation as well as the systemic hemodynamic changes using midazolam and propofol as total intravenous anesthetics (TIVA) in comparison with sevoflurane anesthesia in clipping of ruptured cerebral aneurysm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status III or IV.

排除标准

  • Morbid obese patients.
  • Severe or uncompensated cardiovascular diseases
  • Severe or decompensated renal diseases
  • Severe or decompensated hepatic diseases
  • Severe or decompensated endocrinal diseases.
  • Pregnancy
  • Postpartum
  • Lactating females
  • Allergy to one of the agents used.
  • Severely altered consciousness level.
  • Sitting or prone position during surgery.

研究组 & 干预措施

Total intravenous anesthesia (TIVA)

Experimental

Patients will receive total intravenous anesthesia using Propofol and Midazolam

干预措施: Total intravenous anesthesia (TIVA) (Drug)

Total intravenous anesthesia (TIVA)

Experimental

Patients will receive total intravenous anesthesia using Propofol and Midazolam

干预措施: Rescue fentanyl (Drug)

Inhalation Anesthesia

Active Comparator

Patients will receive Inhalation anesthesia using Sevoflurane

干预措施: Inhalation Anesthesia (Drug)

Inhalation Anesthesia

Active Comparator

Patients will receive Inhalation anesthesia using Sevoflurane

干预措施: Rescue fentanyl (Drug)

结局指标

主要结局

Arterio-Jugular oxygen content difference

时间窗: Immediately before and every 30 min for 6 hour following start of surgery

The differences between arterial and jugular bulb oxygen contents

Cerebral Extraction Rate of O2 (CEO2)

时间窗: Immediately before and every 30 min for 6 hour following start of surgery

Calculated as the differences between arterial and jugular bulb O2 saturations, CEO2 = SaO2 - SjvO2

Estimated cerebral metabolic rate for O2 (eCMRO2)

时间窗: Immediately before and every 30 min for 6 hour following start of surgery

eCMRO2=Ca- jO2 x(PaCO2 ∕ 100), Where Ca jO2 is arterio-jugular O2 content difference. PaCO2 is arterial CO2 tension

Cerebral Blood Flow equivalent (CBFe)

时间窗: Immediately before and every 30 min for 6 hour following start of surgery

: Which is an index of flow metabolism relationship, calculated as a reciprocal of arterio-jugular O2 content difference. CBFe = 1 ∕CaO2-CjvO.

次要结局

  • Mean arterial blood pressure(Immediately before and every 30 min for 6 hour following start of surgery)
  • End tidal carbon dioxide tension(Immediately before and every 30 min for 6 hour following start of surgery)
  • Central venous pressure(Immediately before and every 30 min for 6 hour following start of surgery)
  • Sedation score(For 6 hours from induction of anesthesia)
  • Time for first analgesic request from extubation(For 6 hours from induction of anesthesia)
  • Heart rate(Immediately before and every 30 min for 6 hour following start of surgery)
  • Duration of stay in intensive care unit(For 5 days after surgery)
  • Peripheral oxygen saturation(Immediately before and every 30 min for 6 hour following start of surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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