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

Not Applicable

Withdrawn

• Conditions: Brain Neoplasms
• Interventions: Drug: Propofol + Remifentanil; Drug: Sevoflurane + Remifentanil

• Registration Number: NCT00555984
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-11-07
• Study First Submitted QC: 2007-11-07
• Study First Posted: 2007-11-09
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total Intravenous anesthetic	Propofol + Remifentanil	Intravenous anesthetics (propofol + remifentanil) for maintenance of General Anesthesia
Volatile Anesthetic	Sevoflurane + Remifentanil	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.

Primary Outcome Measures

Name	Time	Method
To study inflammatory changes associated with these two different anesthetic techniques	24 hours post-operatively

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States