Clinical trial NCT00555984: Intravenous Anesthesia Versus Anesthesia With Volatile Agents in Elective Craniotomy for Tumors
Official title: Effect of Total Intravenous Anesthesia Versus Anesthesia With Volatile Agents on Inflammatory Markers Following Elective Craniotomy for Primary Brain Tumor
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Brain Neoplasms
Keywords: Intracranial tumors
Inflammatory markers
Craniotomy
Postoperative complications
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2007-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To study inflammatory changes associated with these two different anesthetic techniques
timeFrame: 24 hours post-operatively
Secondary outcomes:
measure: 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
timeFrame: 4 weeks after discharge
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Rafi Avitsian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Armin Schubert, MD, MBA
role: STUDY_DIRECTOR
References: