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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575521
• Other study ID #: MFM-IRB-14-08-2015
• Status: Completed
• Phase: N/A
• First received: October 7, 2015
• Last updated: November 6, 2017
• Start date: August 2015
• Est. completion date: November 1, 2017

Study information

• Verified date: November 2017
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 1, 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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,

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Surgery

Intervention

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.
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterio-Jugular oxygen content difference		immediately after cannulation (arterial and jugular), every 30 min during surgery and after complete closure of the scalp
Primary	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
Primary	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.
Primary	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	Heart rate		will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp
Secondary	Blood pressure		will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp
Secondary	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
Secondary	Central venous pressure		will be monitored continiously and recorded immediately after intubation, every 30 min during surgery and immediately after closure of the scalp
Secondary	Postoperative level of sedation	all patients will be evaluated using Ramsay sedation scale	every 5 min for 60 min, after extubation
Secondary	Time for first analgesic request from extubation		for 6 hours after surgery
Secondary	Total analgesics received		for 24 hours after surgery
Secondary	Intensive care unit stay		for 10 days after surgery