Brain Neoplasms
Conditions
Keywords
Intracranial tumors, Inflammatory markers, Craniotomy, Postoperative complications
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.
Interventions
Administered intravenously during surgery for maintenance of General Anesthesia
the (Sevoflurane + Remifentanil) arm: Sevoflurane as inhalational agent and Remifentanil as intravenous agent for maintenance of General Anesthesia
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study inflammatory changes associated with these two different anesthetic techniques | 24 hours post-operatively |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 4 weeks after discharge |
Countries
United States
Outcome results
None listed