Clinical trial NCT02510586: Sevoflurane and Hyperperfusion Syndrome
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperperfusion Syndrome
Moyamoya Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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.

Eligibility 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

Primary outcomes:
measure: The incidence of postoperative cerebral hyperperfusion syndrome
timeFrame: postoperative day 15
Secondary outcomes:
measure: The incidence of a new onset postoperative cerebral ischemia
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
measure: The incidence of a new onset postoperative brain hematoma
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
measure: The incidence of unrecovered neurological deficit
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Hee Pyung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.