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

NCT02575521 | Completed DMC

• 1 other identifier: MFM-IRB-14-08-2015
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Brain Tumor; Surgery

Outcome Measures

Primary Outcomes (4)

• Arterio-Jugular oxygen content difference

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

• Estimated cerebral metabolic rate for O2 (eCMRO2)

  eCMRO2=Ca- jO2 x(PaCO2 ∕ 100) Where Ca jO2 is arterio-jugular O2 content difference. PaCO2 is arterial CO2 tension

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

• Cerebral Extraction Rate of O2 (CEO2)

  Calculated as the differences between arterial and jugular bulb O2 saturations, CEO2 = SaO2 - SjvO2

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

• Cerebral Blood Flow equivalent (CBFe)

  Which is an index of flow metabolism relationship, calculated as a reciprocal of arterio-jugular O2 content difference. CBFe = 1 ∕CaO2-CjvO.

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

Secondary Outcomes (8)

• Heart rate

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

• Blood pressure

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

• End-tidal carbon dioxide tension

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

• Central venous pressure

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

• Postoperative level of sedation

  every 5 min for 60 min, after extubation

Study Arms (2)

Propofol-Dexmedetomidine group

PLACEBO COMPARATOR

this group is planned to receive intravenous anaesthesia only

Drug: Propofol-Dexmedetomidine group

Sevoflurane group

ACTIVE COMPARATOR

this group is planned to receive sevoflurane/fentanyl anaesthesia

Drug: Sevoflurane group

Interventions

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.

Propofol-Dexmedetomidine group

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).

Sevoflurane group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ahmed A. Daif, MD

  Anaesthesia and Intensive Care Department, College of Medicine, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 14, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11