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

• ClinicalTrials.gov Identifier: NCT02575521
• Recruitment Status: Completed
• First Posted: October 14, 2015
• Last Update Posted: November 8, 2017
• Sponsor: Mansoura University
• Information provided by (Responsible Party): Mansoura University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Brain Tumor; Surgery	Drug: Propofol-Dexmedetomidine group; Drug: Sevoflurane group	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Supportive Care
• Official Title: Effect of Propofol-Dexmedetomidine Total Intravenous Anaesthesia on Cerebral Oxygenation and Metabolism During Brain Tumor Resection Compared to Sevoflurane Anaesthesia
• Actual Study Start Date: August 2015
• Actual Primary Completion Date: October 2017
• Actual Study Completion Date: November 1, 2017

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Propofol-Dexmedetomidine group; this group is planned to receive intravenous anaesthesia only	Drug: 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.
Active Comparator: Sevoflurane group; this group is planned to receive sevoflurane/fentanyl anaesthesia	Drug: 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).

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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,

Contacts and Locations

Sponsors and Collaborators

Mansoura University

Investigators

• Principal Investigator: Ahmed A. Daif, MD; Anaesthesia and Intensive Care Department, College of Medicine, Mansoura University

More Information

• Responsible Party: Mansoura University
• ClinicalTrials.gov Identifier: NCT02575521
• Other Study ID Numbers: MFM-IRB-14-08-2015
• First Posted: October 14, 2015
• Last Update Posted: November 8, 2017
• Last Verified: November 2017

Additional relevant MeSH terms:

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dexmedetomidine; Propofol; Sevoflurane; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Anesthetics, Inhalation