Sevoflurane and Hyperperfusion Syndrome

Overview

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.

Full Title of Study: “Effect of Sevoflurane-induced Postconditioning on the Incidence of Postoperative Cerebral Hyperperfusion Syndrome After Revascularization Surgery in Adult Patients With Moyamoya Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: August 2018

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.

Interventions

  • Drug: Sevoflurane
    • administer 1.0 MAC (1.7~2.0 vol%) of sevoflurane for 30 minutes after vascular anastomosis completed

Arms, Groups and Cohorts

  • Experimental: Sevo_postconditioning
    • Patients receiving sevoflurane 1.0 minimum alveolar concentration (MAC) for 30 minutes after revascularization competed.
  • No Intervention: Non_postconditioning
    • Patients not receiving sevoflurane postconditioning after revascularization completed

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hee-Pyoung Park, Associate Professor – Seoul National University Hospital
  • Overall Official(s)
    • Hee Pyung Park, MD, PhD, Principal Investigator, Seoul National University Hospital
  • Overall Contact(s)
    • Hee Pyung Park, MD, PhD, 82-2-2072-2466, hppark@snu.ac.kr

References

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.

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.

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