Effect of Total Intravenous Anesthesia Versus Anesthesia With Volatile Agents on Inflammatory Markers Following Elective Craniotomy for Primary Brain Tumor
This is a randomized blinded clinical trial. Patients will be randomized into one of two
groups. One group will receive a volatile anesthetic (sevoflurane)while the other group will
receive intravenous anesthetics (propofol + remifentanil) for maintenance of General
Anesthesia.
The anesthesia team will know the result of randomization at induction. Postoperative data
will be gathered by research personnel who will be blinded to the anesthetic method used.
Patients will be blinded to the anesthetic they receive until after the 4-week outcomes are
collected, when they will have the option to be unblinded.
Peripheral blood samples will be taken a total of 7 times; pre-induction to anesthesia, 15
minutes after surgical positioning, after the tumor is extracted, and at 6,12,18, and 24
hours after emergence from anesthesia.
Patients will be called for follow up every week for 4 weeks following discharge.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
To study inflammatory changes associated with these two different anesthetic techniques
24 hours post-operatively
No
Rafi Avitsian, MD
Principal Investigator
The Cleveland Clinic
United States: Institutional Review Board
Case 4306
NCT00555984
September 2007
March 2010
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |