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

Primary Purpose

Brain Neoplasms

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Propofol + Remifentanil
Sevoflurane + Remifentanil
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Brain Neoplasms focused on measuring Intracranial tumors, Inflammatory markers, Craniotomy, Postoperative complications

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Total Intravenous anesthetic

Volatile Anesthetic

Arm Description

Intravenous anesthetics (propofol + remifentanil) for maintenance of General Anesthesia

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.

Outcomes

Primary Outcome Measures

To study inflammatory changes associated with these two different anesthetic techniques

Secondary Outcome Measures

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

Full Information

First Posted
November 7, 2007
Last Updated
April 19, 2017
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00555984
Brief Title
Intravenous Anesthesia Versus Anesthesia With Volatile Agents in Elective Craniotomy for Tumors
Acronym
TIVA
Official Title
Effect of Total Intravenous Anesthesia Versus Anesthesia With Volatile Agents on Inflammatory Markers Following Elective Craniotomy for Primary Brain Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
PI decision to terminate. No usable data collected
Study Start Date
September 2007 (Actual)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms
Keywords
Intracranial tumors, Inflammatory markers, Craniotomy, Postoperative complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total Intravenous anesthetic
Arm Type
Active Comparator
Arm Description
Intravenous anesthetics (propofol + remifentanil) for maintenance of General Anesthesia
Arm Title
Volatile Anesthetic
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol + Remifentanil
Other Intervention Name(s)
Intravenous anesthetics
Intervention Description
Administered intravenously during surgery for maintenance of General Anesthesia
Intervention Type
Drug
Intervention Name(s)
Sevoflurane + Remifentanil
Other Intervention Name(s)
Inhalational anesthetics
Intervention Description
the (Sevoflurane + Remifentanil) arm: Sevoflurane as inhalational agent and Remifentanil as intravenous agent for maintenance of General Anesthesia
Primary Outcome Measure Information:
Title
To study inflammatory changes associated with these two different anesthetic techniques
Time Frame
24 hours post-operatively
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafi Avitsian, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Armin Schubert, MD, MBA
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study terminated early

Learn more about this trial

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

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