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临床试验/NCT02575521
NCT02575521已完成不适用

Effect of Propofol-Dexmedetomidine Total Intravenous Anaesthesia on Cerebral Oxygenation and Metabolism During Brain Tumor Resection Compared to Sevoflurane Anaesthesia

Mansoura University0 个研究点目标入组 50 人开始时间: 2015年8月最近更新:
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
主要终点
Arterio-Jugular oxygen content difference

研究概览

简要总结

Despite theoretical benefits of intravenous 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 intra-cranial pressure (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 haemodaynamics and global cerebral oxygenation as well as the systemic haemodaynamic changes using dexmedetomidine, propofol and fentanyl as total intravenous anaesthestics (TIVA) in comparison with sevoflurane - fentanyl anesthesia in brain tumor resection.

Indicators of global cerebral oxygenation and haemodynamics will be calculated using jugular bulb and peripheral arterial blood sampling.

  • Induction: propofol, 1.5 - 2 mg/kg.
  • Muscle Relaxants: atracurium, 0.5 mg/kg with induction and 0.1 mg/kg/20min. for maintenance.
  • Cannulation: Arterial cannula: under complete aseptic conditions 20G cannula was inserted into the radial artery of non dominant hand after performing modified Allen's test and local infiltration of 0.5ml xylocaine 2%.

Central venous catheter: A suitable central venous catheter will be inserted into Rt subclavian vein under complete aseptic technique, its correct position will be confirmed with chest X-Ray.

Jugular bulb catheterization: Under strict sterile technique the right internal jugular vein will be cannulated in a retrograde technique with confirmation of the catheter tip position using X-Ray (C- arm). Puncture site will be at the level of cricoid cartilage behind the anterior border of the sternocleido-mastoid muscle.

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 (Care Provider)

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.
  • Patients scheduled for elective brain tumor resection

排除标准

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

研究组 & 干预措施

Propofol-Dexmedetomidine group

Placebo Comparator

this group is planned to receive intravenous anaesthesia only

干预措施: Propofol-Dexmedetomidine group (Drug)

Sevoflurane group

Active Comparator

this group is planned to receive sevoflurane/fentanyl anaesthesia

干预措施: Sevoflurane group (Drug)

结局指标

主要结局

Arterio-Jugular oxygen content difference

时间窗: immediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalp

Estimated cerebral metabolic rate for O2 (eCMRO2)

时间窗: immediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalp

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

Cerebral Extraction Rate of O2 (CEO2)

时间窗: immediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalp.

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

Cerebral Blood Flow equivalent (CBFe)

时间窗: immediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalp

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

  • Time for first analgesic request from extubation(for 6 hours after surgery)
  • Total analgesics received(for 24 hours after surgery)
  • Heart rate(will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp)
  • Blood pressure(will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp)
  • End-tidal carbon dioxide tension(will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp)
  • Central venous pressure(will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp)
  • Postoperative level of sedation(every 5 min for 60 min, after extubation)
  • Intensive care unit stay(for 10 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

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