Brain NeoplasmsTIVANCT00555984
Intravenous Anesthesia Versus Anesthesia With Volatile Agents in Elective Craniotomy for Tumors
A study testing Propofol + Remifentanil and Sevoflurane + Remifentanil in people with Brain Neoplasms, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- Propofol + Remifentanil and Sevoflurane + Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing general anesthesia for elective surgical excision of a primary brain tumor
- Age: Older than 18
- New and recurrent cases will be included
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Total Intravenous Anesthesia Versus Anesthesia With Volatile Agents on Inflammatory Markers Following Elective Craniotomy for Primary Brain Tumor
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.
Read the 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.
- Conditions
- Brain Neoplasms
- Being tested
- Propofol + Remifentanil, Sevoflurane + Remifentanil
- Keywords
- Intracranial tumors, Inflammatory markers, Craniotomy, Postoperative complications
- Medical subject headings
- Brain Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol + RemifentanilDrug
Also called Intravenous anesthetics
Administered intravenously during surgery for maintenance of General Anesthesia
Sevoflurane + RemifentanilDrug
Also called Inhalational anesthetics
the (Sevoflurane + Remifentanil) arm: Sevoflurane as inhalational agent and Remifentanil as intravenous agent for maintenance of General Anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Total Intravenous anesthetic | Active comparator | Intravenous anesthetics (propofol + remifentanil) for maintenance of General Anesthesia Receives: Drug: Propofol + Remifentanil |
| Volatile Anesthetic | Active comparator | 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. Receives: Drug: Sevoflurane + Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study inflammatory changes associated with these two different anesthetic techniques
Measured: 24 hours post-operatively
Secondary outcomes (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
Measured: 4 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: PI decision to terminate. No usable data collected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafi Avitsian, MD, Principal investigator, The Cleveland ClinicArmin Schubert, MD, MBA, Study director, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555984
- Sponsor's protocol ID
- Case 4306
- Acronym
- TIVA
- Status last verified
- Apr 2017
- First submitted
- 7 Nov 2007
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Study terminated early
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Total Intravenous Anesthesia Versus Anesthesia With Volatile Agents on Inflammatory Markers Following Elective Craniotomy for Primary Brain Tumor
- ClinicalTrials.gov ID
- NCT00555984
- Acronym / sponsor ID
- TIVA / Case 4306
- Conditions
- Brain Neoplasms
- Keywords
- Intracranial tumors, Inflammatory markers, Craniotomy, Postoperative complications
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decision to terminate. No usable data collected
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Sep 2007 (actual)
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 9 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Intravenous anesthetic | Active comparator | Drug: Propofol + RemifentanilIntravenous anesthetics (propofol + remifentanil) for maintenance of General Anesthesia |
| Volatile Anesthetic | Active comparator | Drug: Sevoflurane + RemifentanilInhalational 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing general anesthesia for elective surgical excision of a primary brain tumor
- Age: Older than 18
- New and recurrent cases will be included
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol + RemifentanilAlso: Intravenous anestheticsAdministered intravenously during surgery for maintenance of General Anesthesia | Drug | Total Intravenous anesthetic |
| Sevoflurane + RemifentanilAlso: Inhalational anestheticsthe (Sevoflurane + Remifentanil) arm: Sevoflurane as inhalational agent and Remifentanil as intravenous agent for maintenance of General Anesthesia | Drug | Volatile Anesthetic |
Primary outcome
To study inflammatory changes associated with these two different anesthetic techniques
Time frame: 24 hours post-operatively
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Individual participant dataSharing planned: No. Study terminated early
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafi Avitsian, MD principal investigator
The Cleveland Clinic
Armin Schubert, MD, MBA study director
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol + Remifentanil and Sevoflurane + Remifentanil in people with Brain Neoplasms, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study inflammatory changes associated with these two different anesthetic techniques (time frame: 24 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.