- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02510586
Sevoflurane and Hyperperfusion Syndrome
July 26, 2015 updated by: Hee-Pyoung Park, Seoul National University Hospital
Effect of Sevoflurane-induced Postconditioning on the Incidence of Postoperative Cerebral Hyperperfusion Syndrome After Revascularization Surgery in Adult Patients With Moyamoya Disease
The aim of the present study is to evaluate the effect of sevoflurane postconditioning on the incidence of postoperative hyperperfusion syndrome following revascularization surgery in moyamoya patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Postoperative hyperperfusion syndrome is a common complication in moyamoya disease patients receiving revascularization surgery.
Previously its incidence has been reported to be 17~50%, but little remains regarding frequency of reperfusion injury after revascularization surgery in patients with moyamoya disease.
Volatile anesthetics such as sevoflurane has been introduced clinically to reduce reperfusion injury and preconditioning with sevoflurane induced ischemic tolerance like as ischemic preconditioning.
However, there was no report on the neuroprotective effect of sevoflurane postconditioning on ischemic/reperfusion injury in human brain.
Therefore, We evaluated the neuroprotective effect of sevoflurane postconditioning on the incidence of postoperative hyperperfusion syndrome after revascularization surgery in moyamoya disease patients.
Study Type
Interventional
Enrollment (Anticipated)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients receiving cerebral revascularization surgery due to moyamoya disease
Exclusion Criteria:
- Patients who do not agree to the study
- Patients with uncontrolled diabetes or hypertension
- Patients using cyclooxygenase2 inhibitor or with previously using cyclooxygenase2 inhibitor
- Patients with acute renal failure
- Patients with previous intervention related with moyamoya disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sevo_postconditioning
Patients receiving sevoflurane 1.0 minimum alveolar concentration (MAC) for 30 minutes after revascularization competed.
|
administer 1.0 MAC (1.7~2.0 vol%) of sevoflurane for 30 minutes after vascular anastomosis completed
Other Names:
|
No Intervention: Non_postconditioning
Patients not receiving sevoflurane postconditioning after revascularization completed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of postoperative cerebral hyperperfusion syndrome
Time Frame: postoperative day 15
|
Cerebral hyperperfusion syndrome was defined if all the following four criteria were met: i) new development of postoperative focal neurological deficits, ii) a delayed neurological deficits which were not shown in the immediate postoperative period; iii) postoperative reversible neurological deficits which were completely resolved within 15 days after operation; iii) neither definite haematomas nor definite acute infarction on a brain CT scan, on diffusion magnetic resonance imaging, or both.
|
postoperative day 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of a new onset postoperative cerebral ischemia
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
|
cerebral ischemia is diagnosed by clinical symptoms and radiologic imaging (CT or MRI).
|
participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
|
The incidence of a new onset postoperative brain hematoma
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
|
postoperative brain hematoma is diagnosed by clinical symptoms and radiologic imaging (CT or MRI).
|
participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
|
The incidence of unrecovered neurological deficit
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
|
the incidence of postoperative neurological symptoms which persisted or not fully recovered until the patient's discharge.
|
participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hee Pyung Park, MD, PhD, Seoul National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Payne RS, Akca O, Roewer N, Schurr A, Kehl F. Sevoflurane-induced preconditioning protects against cerebral ischemic neuronal damage in rats. Brain Res. 2005 Feb 9;1034(1-2):147-52. doi: 10.1016/j.brainres.2004.12.006.
- Ishii K, Morishige M, Anan M, Sugita K, Abe E, Kubo T, Fujiki M, Kobayashi H. Superficial temporal artery-to-middle cerebral artery anastomosis with encephalo-duro-myo-synangiosis as a modified operative procedure for moyamoya disease. Acta Neurochir Suppl. 2010;107:95-9. doi: 10.1007/978-3-211-99373-6_15.
- Kim SH, Choi JU, Yang KH, Kim TG, Kim DS. Risk factors for postoperative ischemic complications in patients with moyamoya disease. J Neurosurg. 2005 Nov;103(5 Suppl):433-8. doi: 10.3171/ped.2005.103.5.0433.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Anticipated)
August 1, 2018
Study Completion (Anticipated)
September 1, 2018
Study Registration Dates
First Submitted
July 24, 2015
First Submitted That Met QC Criteria
July 26, 2015
First Posted (Estimate)
July 29, 2015
Study Record Updates
Last Update Posted (Estimate)
July 29, 2015
Last Update Submitted That Met QC Criteria
July 26, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arterial Occlusive Diseases
- Disease
- Carotid Artery Diseases
- Cerebral Arterial Diseases
- Intracranial Arterial Diseases
- Syndrome
- Moyamoya Disease
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Anesthetics, Inhalation
- Sevoflurane
Other Study ID Numbers
- Sevo_postconditioning
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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