Intravenous Anesthesia Versus Anesthesia With Volatile Agents in Elective Craniotomy for Tumors (TIVA)
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Purpose
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 | Intervention |
|---|---|
|
Brain Neoplasms |
Drug: Propofol + Remifentanil Drug: Sevoflurane + Remifentanil |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
- To study inflammatory changes associated with these two different anesthetic techniques [ Time Frame: 24 hours post-operatively ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | September 2007 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Sevoflorane 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: | Rafi Avitsian, MD | The Cleveland Clinic |
| Study Director: | Armin Schubert, MD, MBA | The Cleveland Clinic |
More Information
No publications provided
| Responsible Party: | Rafi Avitsian, Section Head, Neuroanesthesia, The Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT00555984 History of Changes |
| Obsolete Identifiers: | NCT00524082 |
| Other Study ID Numbers: | Case 4306 |
| Study First Received: | November 7, 2007 |
| Last Updated: | August 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Cleveland Clinic:
|
Intracranial tumors Inflammatory markers Craniotomy Postoperative complications |
Additional relevant MeSH terms:
|
Brain Neoplasms Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Anesthetics Propofol Sevoflurane Remifentanil Anesthetics, Intravenous Anesthetics, Inhalation |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, General Hypnotics and Sedatives Platelet Aggregation Inhibitors Hematologic Agents Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013