Intravenous Anesthesia Versus Anesthesia With Volatile Agents in Elective Craniotomy for Tumors (TIVA)
|Brain Neoplasms||Drug: Propofol + Remifentanil Drug: Sevoflurane + Remifentanil|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effect of Total Intravenous Anesthesia Versus Anesthesia With Volatile Agents on Inflammatory Markers Following Elective Craniotomy for Primary Brain Tumor|
- To study inflammatory changes associated with these two different anesthetic techniques [ Time Frame: 24 hours post-operatively ]
- Because of the linkage between cytokines, thrombotic disease, tissue inflammation and brain edema, we plan to monitor a composite outcome derived from occurrence of DVT, PE, new neurologic deficit, postoperative infection and respiratory failure [ Time Frame: 4 weeks after discharge ]
|Actual Study Start Date:||September 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Total Intravenous anesthetic
Intravenous anesthetics (propofol + remifentanil) for maintenance of General Anesthesia
Drug: Propofol + Remifentanil
Administered intravenously during surgery for maintenance of General Anesthesia
Other Name: Intravenous anesthetics
Active Comparator: Volatile Anesthetic
Inhalational anesthetics (sevoflurane+remifentanil) for maintenance of General Anesthesia. Patients receive Sevoflurane as a volatile anesthetic and remifentanil as an IV agent for maintenance of general anesthesia.
Drug: Sevoflurane + Remifentanil
the (Sevoflurane + Remifentanil) arm: Sevoflurane as inhalational agent and Remifentanil as intravenous agent for maintenance of General Anesthesia
Other Name: Inhalational anesthetics
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555984
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Rafi Avitsian, MD||The Cleveland Clinic|
|Study Director:||Armin Schubert, MD, MBA||The Cleveland Clinic|