Intravenous Anesthesia Versus Anesthesia With Volatile Agents in Elective Craniotomy for Tumors (TIVA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rafi Avitsian, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00555984
First received: November 7, 2007
Last updated: August 1, 2012
Last verified: August 2012

November 7, 2007
August 1, 2012
September 2007
August 2009   (final data collection date for primary outcome measure)
To study inflammatory changes associated with these two different anesthetic techniques [ Time Frame: 24 hours post-operatively ] [ Designated as safety issue: No ]
To study inflammatory changes associated with these two different anesthetic techniques [ Time Frame: 24 hours post-operatively ]
Complete list of historical versions of study NCT00555984 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
Intravenous Anesthesia Versus Anesthesia With Volatile Agents in Elective Craniotomy for Tumors
Effect of Total Intravenous Anesthesia Versus Anesthesia With Volatile Agents on Inflammatory Markers Following Elective Craniotomy for Primary Brain Tumor

If the anesthetic regimen can influence the serum level of inflammatory cytokines and if the levels of cytokines are related to the incidence of post operative complications, these complications may be a function of the anesthetic method. In an effort to find the best anesthetic regimen for patients undergoing craniotomy for intracranial tumors, the researchers will compare the effect of volatile anesthetic with that of total intravenous anesthesia (TIVA) on cytokine levels. The researchers will also compare the composite incidence of some common major post-operative complications after craniotomy for intracranial malignancy.

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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Brain Neoplasms
  • Drug: Propofol + Remifentanil
    Administered intravenously during surgery for maintenance of General Anesthesia
    Other Name: Intravenous anesthetics
  • 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
  • Active Comparator: Total Intravenous anesthetic
    Intravenous anesthetics (propofol + remifentanil) for maintenance of General Anesthesia
    Intervention: Drug: Propofol + Remifentanil
  • Active Comparator: Volatile Anesthetic
    Inhalational anesthetics (sevoflurane+remifentanil) for maintenance of General Anesthesia. Patients receive Sevoflorane as a volatile anesthetic and remifentanil as an IV agent for maintenance of general anesthesia.
    Intervention: Drug: Sevoflurane + Remifentanil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2010
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing general anesthesia for elective surgical excision of a primary brain tumor
  • Age: Older than 18
  • New and recurrent cases will be included

Exclusion Criteria:

  • Patient refusal
  • Emergency craniotomy
  • Craniotomy after head injuries or intracranial bleeding
  • Patients with active inflammatory processes such as infection or immunologic illnesses known to increase baseline immunologic markers
  • Preoperative diagnosis of DVT by lower extremity ultrasound or symptoms
  • Preoperative pulmonary infiltrative disease (pulmonary fibrosis, sarcoid, etc.)
  • Pregnancy
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00555984
Case 4306
Yes
Rafi Avitsian, The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Rafi Avitsian, MD The Cleveland Clinic
Study Director: Armin Schubert, MD, MBA The Cleveland Clinic
The Cleveland Clinic
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP