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Sevoflurane and Hyperperfusion Syndrome

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ClinicalTrials.gov Identifier: NCT02510586
Recruitment Status : Unknown
Verified July 2015 by Hee-Pyoung Park, Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 29, 2015
Last Update Posted : July 29, 2015
Sponsor:
Information provided by (Responsible Party):
Hee-Pyoung Park, Seoul National University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hyperperfusion Syndrome Moyamoya Disease Drug: Sevoflurane Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: Effect of Sevoflurane-induced Postconditioning on the Incidence of Postoperative Cerebral Hyperperfusion Syndrome After Revascularization Surgery in Adult Patients With Moyamoya Disease
Study Start Date : August 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sevo_postconditioning
Patients receiving sevoflurane 1.0 minimum alveolar concentration (MAC) for 30 minutes after revascularization competed.
 Drug: Sevoflurane
administer 1.0 MAC (1.7~2.0 vol%) of sevoflurane for 30 minutes after vascular anastomosis completed
Other Name: Sevorane
No Intervention: Non_postconditioning
Patients not receiving sevoflurane postconditioning after revascularization completed


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510586


Contacts
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Contact: Hee Pyung Park, MD, PhD 82-2-2072-2466 hppark@snu.ac.kr
Contact: Hyungseok Seo, MD 82-2-2072-2469 seohyungseok@gmail.com

Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hee Pyung Park, MD, PhD Seoul National University Hospital
More Information
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Publications:

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Responsible Party: Hee-Pyoung Park, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02510586    
Other Study ID Numbers: Sevo_postconditioning
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Moyamoya Disease
Syndrome
Disease
Pathologic Processes
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs