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Effect of Total Intravenous Anesthesia Versus Anesthesia With Volatile Agents on Inflammatory Markers Following Elective Craniotomy for Primary Brain Tumor


N/A
18 Years
80 Years
Not Enrolling
Both
Brain Neoplasms

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

To study inflammatory changes associated with these two different anesthetic techniques

Outcome Time Frame:

24 hours post-operatively

Safety Issue:

No

Principal Investigator

Rafi Avitsian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Institutional Review Board

Study ID:

Case 4306

NCT ID:

NCT00555984

Start Date:

September 2007

Completion Date:

March 2010

Related Keywords:

  • Brain Neoplasms
  • Intracranial tumors
  • Inflammatory markers
  • Craniotomy
  • Postoperative complications
  • Brain Neoplasms
  • Neoplasms

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195