Effect of Propofol-Dexmedetomidine on Cerebral Oxygenation and Metabolism During Brain Tumor Resection
NCT ID: NCT02575521
Last Updated: 2017-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2015-08-31
2017-11-01
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Propofol-Dexmedetomidine group
this group is planned to receive intravenous anaesthesia only
Propofol-Dexmedetomidine group
Porofol (1.5-2 mg/kg/h) infusion, Dexmedetomidine (0.2-1µg/kg/h) infusion and Fentanyl in repeated doses (50µ) when needed (heart rate or mean arterial blood pressure increase more than 20% of the basal value). Maintenance infusions will start immediately after induction.
Sevoflurane group
this group is planned to receive sevoflurane/fentanyl anaesthesia
Sevoflurane group
Sevoflurane at a concentration of 2-2.5%., Fentanyl in repeated doses (50µ) when needed (heart rate or mean arterial blood pressure increase more than 20% of the basal value).
Interventions
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Propofol-Dexmedetomidine group
Porofol (1.5-2 mg/kg/h) infusion, Dexmedetomidine (0.2-1µg/kg/h) infusion and Fentanyl in repeated doses (50µ) when needed (heart rate or mean arterial blood pressure increase more than 20% of the basal value). Maintenance infusions will start immediately after induction.
Sevoflurane group
Sevoflurane at a concentration of 2-2.5%., Fentanyl in repeated doses (50µ) when needed (heart rate or mean arterial blood pressure increase more than 20% of the basal value).
Eligibility Criteria
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Inclusion Criteria
* Patients scheduled for elective brain tumor resection
Exclusion Criteria
* 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,
20 Years
60 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Principal Investigators
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Ahmed A. Daif, MD
Role: PRINCIPAL_INVESTIGATOR
Anaesthesia and Intensive Care Department, College of Medicine, Mansoura University
Other Identifiers
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MFM-IRB-14-08-2015
Identifier Type: -
Identifier Source: org_study_id