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Effect of Propofol-Dexmedetomidine on Cerebral Oxygenation and Metabolism During Brain Tumor Resection

M

Mansoura University

Status

Completed

Conditions

Brain Tumor
Surgery

Treatments

Drug: Propofol-Dexmedetomidine group
Drug: Sevoflurane group

Study type

Interventional

Funder types

Other

Identifiers

NCT02575521
MFM-IRB-14-08-2015

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • American Society of Anesthesiologists physical status III or IV.
  • Patients scheduled for elective brain tumor resection

Exclusion criteria

  • 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,

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups, including a placebo group

Propofol-Dexmedetomidine group
Placebo Comparator group
Description:
this group is planned to receive intravenous anaesthesia only
Treatment:
Drug: Propofol-Dexmedetomidine group
Sevoflurane group
Active Comparator group
Description:
this group is planned to receive sevoflurane/fentanyl anaesthesia
Treatment:
Drug: Sevoflurane group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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