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

Brain Neoplasms Clinical Trial

— TIVA  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00555984
• Other study ID #: Case 4306
• Status: Withdrawn
• Phase: N/A
• First received: November 7, 2007
• Last updated: April 19, 2017
• Start date: September 2007
• Est. completion date: March 2010

Study information

• Verified date: April 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00524082

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

Drug:
• Propofol + Remifentanil
Administered intravenously during surgery for maintenance of General Anesthesia
• Sevoflurane + Remifentanil
the (Sevoflurane + Remifentanil) arm: Sevoflurane as inhalational agent and Remifentanil as intravenous agent for maintenance of General Anesthesia

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study inflammatory changes associated with these two different anesthetic techniques		24 hours post-operatively
Secondary	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