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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02575521
Enrollment
50
Registered
2015-10-14
Start date
2015-08-31
Completion date
2017-11-01
Last updated
2017-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor, Surgery

Brief summary

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.

Detailed 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.

Interventions

DRUGPropofol-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 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).

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
Cerebral Extraction Rate of O2 (CEO2)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
Arterio-Jugular oxygen content differenceimmediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalp
Estimated cerebral metabolic rate for O2 (eCMRO2)immediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalpeCMRO2=Ca- jO2 x(PaCO2 ∕ 100) Where Ca jO2 is arterio-jugular O2 content difference. PaCO2 is arterial CO2 tension
Cerebral Blood Flow equivalent (CBFe)immediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalpWhich is an index of flow metabolism relationship, calculated as a reciprocal of arterio-jugular O2 content difference. CBFe = 1 ∕CaO2-CjvO.

Secondary

MeasureTime frameDescription
Postoperative level of sedationevery 5 min for 60 min, after extubationall patients will be evaluated using Ramsay sedation scale
Time for first analgesic request from extubationfor 6 hours after surgery
Heart ratewill be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp
Intensive care unit stayfor 10 days after surgery
Total analgesics receivedfor 24 hours after surgery
Blood pressurewill be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp
End-tidal carbon dioxide tensionwill be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp
Central venous pressurewill be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026