Intravenous Anesthesia Versus Anesthesia With Volatile Agents in Elective Craniotomy for Tumors (TIVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00555984
Recruitment Status : Withdrawn (PI decision to terminate. No usable data collected)
First Posted : November 9, 2007
Last Update Posted : April 20, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Brain Neoplasms Drug: Propofol + Remifentanil Drug: Sevoflurane + Remifentanil Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Total Intravenous Anesthesia Versus Anesthesia With Volatile Agents on Inflammatory Markers Following Elective Craniotomy for Primary Brain Tumor
Actual Study Start Date : September 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Total Intravenous anesthetic
Intravenous anesthetics (propofol + remifentanil) for maintenance of General Anesthesia
Drug: Propofol + Remifentanil
Administered intravenously during surgery for maintenance of General Anesthesia
Other Name: Intravenous anesthetics
Active Comparator: Volatile Anesthetic
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
the (Sevoflurane + Remifentanil) arm: Sevoflurane as inhalational agent and Remifentanil as intravenous agent for maintenance of General Anesthesia
Other Name: Inhalational anesthetics

Primary Outcome Measures :
  1. To study inflammatory changes associated with these two different anesthetic techniques [ Time Frame: 24 hours post-operatively ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00555984

United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Rafi Avitsian, MD The Cleveland Clinic
Study Director: Armin Schubert, MD, MBA The Cleveland Clinic

Responsible Party: The Cleveland Clinic Identifier: NCT00555984     History of Changes
Obsolete Identifiers: NCT00524082
Other Study ID Numbers: Case 4306
First Posted: November 9, 2007    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study terminated early

Keywords provided by The Cleveland Clinic:
Intracranial tumors
Inflammatory markers
Postoperative complications

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anesthetics, Intravenous
Anesthetics, Inhalation
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, General
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors