Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care	Active	18 to 80	Other	Case 4306 NCT00555984

Trial Description

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 malignant 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.

Further Study Information

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 malignant 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Cleveland Clinic Taussig Cancer Center

Rafi Avitsian, MD

Principal Investigator

Armin Schubert, MD, MBA

Study Director

Rafi Avitsian, MD		Ph: 216-444-9735
		Email: avitsir@ccf.org

Armin Schubert, MD, MBA		Ph: 216-444-3754
		Email: schubea@ccf.org

U.S.A.
Ohio
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Nancy Graham, BA, CCRP	Ph: 216-445-2750
			Email: grahamn@ccf.org
		Ankit Maheshwari, MD	Ph: 216-444-6796
			Email: mahesha@ccf.org
		Rafi Avitsian, MD	Principal Investigator
		Armin Schubert, MD, MBA	Sub-Investigator
		Michael A. Vogelbaum	Sub-Investigator
		Juan Cata, MD	Sub-Investigator
		Manju Bhat, Ph.D.	Sub-Investigator
		Edward Mascha, Ph.D.	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00555984
Information obtained from ClinicalTrials.gov on March 18, 2009