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

The Cleveland Clinic

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Conditions

Brain Neoplasms

Interventions

Propofol + RemifentanilDRUG

Administered intravenously during surgery for maintenance of General Anesthesia

Sevoflurane + RemifentanilDRUG

the (Sevoflurane + Remifentanil) arm: Sevoflurane as inhalational agent and Remifentanil as intravenous agent for maintenance of General Anesthesia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

To study inflammatory changes associated with these two different anesthetic techniques

Time frame: 24 hours post-operatively

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.