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

Primary Purpose

Brain Tumor, Surgery

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Propofol-Dexmedetomidine group

Sevoflurane group

About this trial

This is an interventional supportive care trial for Brain Tumor

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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,

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Propofol-Dexmedetomidine group

Sevoflurane group

Arm Description

this group is planned to receive intravenous anaesthesia only

this group is planned to receive sevoflurane/fentanyl anaesthesia

Outcomes

Primary Outcome Measures

Arterio-Jugular oxygen content difference

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

Cerebral Extraction Rate of O2 (CEO2)

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

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.

Secondary Outcome Measures

Heart rate

Blood pressure

End-tidal carbon dioxide tension

Central venous pressure

Postoperative level of sedation

all patients will be evaluated using Ramsay sedation scale

Time for first analgesic request from extubation

Total analgesics received

Intensive care unit stay

Full Information

NCT ID

NCT02575521

First Posted

October 7, 2015

Last Updated

November 6, 2017

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT02575521

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

August 2015 (Actual)

Primary Completion Date

October 2017 (Actual)

Study Completion Date

November 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mansoura University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Tumor, Surgery

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Propofol-Dexmedetomidine group

Arm Type

Placebo Comparator

Arm Description

this group is planned to receive intravenous anaesthesia only

Arm Title

Sevoflurane group

Arm Type

Active Comparator

Arm Description

this group is planned to receive sevoflurane/fentanyl anaesthesia

Intervention Type

Drug

Intervention Name(s)

Propofol-Dexmedetomidine group

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Sevoflurane group

Intervention Description

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 Outcome Measure Information:

Title

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

Title

Estimated cerebral metabolic rate for O2 (eCMRO2)

Description

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

Time Frame

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

Title

Cerebral Extraction Rate of O2 (CEO2)

Description

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

Time Frame

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

Title

Cerebral Blood Flow equivalent (CBFe)

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

Title

Postoperative level of sedation

Description

all patients will be evaluated using Ramsay sedation scale

Time Frame

every 5 min for 60 min, after extubation

Title

Time for first analgesic request from extubation

Time Frame

for 6 hours after surgery

Title

Total analgesics received

Time Frame

for 24 hours after surgery

Title

Intensive care unit stay

Time Frame

for 10 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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,

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed A. Daif, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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