Sevoflurane and Hyperperfusion Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02510586|
Recruitment Status : Not yet recruiting
First Posted : July 29, 2015
Last Update Posted : July 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hyperperfusion Syndrome Moyamoya Disease||Drug: Sevoflurane||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||152 participants|
|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|
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 Name: Sevorane
No Intervention: Non_postconditioning
Patients not receiving sevoflurane postconditioning after revascularization completed
- 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.
- 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).
- 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).
- 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.
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
|Contact: Hee Pyung Park, MD, PhDfirstname.lastname@example.org|
|Contact: Hyungseok Seo, MDemail@example.com|
|Principal Investigator:||Hee Pyung Park, MD, PhD||Seoul National University Hospital|