Intravenous Anesthesia Versus Anesthesia With Volatile Agents in Elective Craniotomy for Tumors

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Brain Neoplasms

Intervention / Treatment
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* Drug: Propofol + Remifentanil
* Drug: Sevoflurane + Remifentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total Intravenous anesthetic<br>Intravenous anesthetics (propofol + remifentanil) for maintenance of General Anesthesia | Drug: Propofol + Remifentanil<br>* Administered intravenously during surgery for maintenance of General Anesthesia<br>* Other names: Intravenous anesthetics;|
| Active Comparator: Volatile Anesthetic<br>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<br>* the (Sevoflurane + Remifentanil) arm: Sevoflurane as inhalational agent and Remifentanil as intravenous agent for maintenance of General Anesthesia<br>* Other names: Inhalational anesthetics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study inflammatory changes associated with these two different anesthetic techniques |  | 24 hours post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial tumors, Inflammatory markers, Craniotomy, Postoperative complications