NCT02510586

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

3 years

First QC Date

July 24, 2015

Last Update Submit

July 26, 2015

Conditions

Hyperperfusion SyndromeMoyamoya Disease

Outcome Measures

Primary Outcomes (1)

  • The incidence of postoperative cerebral hyperperfusion syndrome

    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 Outcomes (3)

  • The incidence of a new onset postoperative cerebral ischemia

    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

    participants will be followed for the duration of hospital stay, an expected average of 3 weeks.

  • The incidence of unrecovered neurological deficit

    participants will be followed for the duration of hospital stay, an expected average of 3 weeks.

Study Arms (2)

Sevo_postconditioning

EXPERIMENTAL

Patients receiving sevoflurane 1.0 minimum alveolar concentration (MAC) for 30 minutes after revascularization competed.

Drug: Sevoflurane

Non_postconditioning

NO INTERVENTION

Patients not receiving sevoflurane postconditioning after revascularization completed

Interventions

SevofluraneDRUG

administer 1.0 MAC (1.7\~2.0 vol%) of sevoflurane for 30 minutes after vascular anastomosis completed

Also known as: Sevorane
Sevo_postconditioning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients receiving cerebral revascularization surgery due to moyamoya disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 15713266BACKGROUND

  • 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.

    PMID: 19953378BACKGROUND

  • 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.

    PMID: 16302615BACKGROUND

MeSH Terms

Conditions

Moyamoya Disease

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Hee Pyung Park, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Pyung Park, MD, PhD

CONTACT

82-2-2072-2466hppark@snu.ac.kr

Hyungseok Seo, MD

CONTACT

82-2-2072-2469seohyungseok@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 24, 2015

First Posted

July 29, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2018

Study Completion

September 1, 2018

Last Updated

July 29, 2015

Record last verified: 2015-07