- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00555984
Intravenous Anesthesia Versus Anesthesia With Volatile Agents in Elective Craniotomy for Tumors (TIVA)
Effect of Total Intravenous Anesthesia Versus Anesthesia With Volatile Agents on Inflammatory Markers Following Elective Craniotomy for Primary Brain Tumor
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Total Intravenous anesthetic
Intravenous anesthetics (propofol + remifentanil) for maintenance of General Anesthesia
|
Administered intravenously during surgery for maintenance of General Anesthesia
Other Names:
|
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.
|
the (Sevoflurane + Remifentanil) arm: Sevoflurane as inhalational agent and Remifentanil as intravenous agent for maintenance of General Anesthesia
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To study inflammatory changes associated with these two different anesthetic techniques
Time Frame: 24 hours post-operatively
|
24 hours post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
4 weeks after discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rafi Avitsian, MD, The Cleveland Clinic
- Study Director: Armin Schubert, MD, MBA, The Cleveland Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Brain Neoplasms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, General
- Platelet Aggregation Inhibitors
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Anesthetics, Inhalation
- Anesthetics
- Remifentanil
- Propofol
- Sevoflurane
- Anesthetics, Intravenous
Other Study ID Numbers
- Case 4306
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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