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NCT Number: NCT02575521

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

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.

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Key information

Conditions

Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Surgery

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Propofol-Dexmedetomidine group

Drug

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

Drug

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).

Primary outcomes

  1. Arterio-Jugular oxygen content difference

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

  2. Estimated cerebral metabolic rate for O2 (eCMRO2)

    Time frame: 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

  3. Cerebral Extraction Rate of O2 (CEO2)

    Time frame: 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

  4. Cerebral Blood Flow equivalent (CBFe)

    Time frame: 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.

Secondary outcomes

  1. Heart rate

    Time frame: will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp

  2. Blood pressure

    Time frame: will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp

  3. End-tidal carbon dioxide tension

    Time frame: will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp

  4. Central venous pressure

    Time frame: will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp

  5. Postoperative level of sedation

    Time frame: every 5 min for 60 min, after extubation

    all patients will be evaluated using Ramsay sedation scale

  6. Time for first analgesic request from extubation

    Time frame: for 6 hours after surgery

  7. Total analgesics received

    Time frame: for 24 hours after surgery

  8. Intensive care unit stay

    Time frame: for 10 days after surgery

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 14, 2015
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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