Sevoflurane and Hyperperfusion Syndrome

July 26, 2015 updated by: Hee-Pyoung Park, Seoul National University Hospital

Effect of Sevoflurane-induced Postconditioning on the Incidence of Postoperative Cerebral Hyperperfusion Syndrome After Revascularization Surgery in Adult Patients With Moyamoya Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hee Pyung Park, MD, PhD
  • Phone Number: 82-2-2072-2466
  • Email: hppark@snu.ac.kr

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Sevorane
No Intervention: Non_postconditioning
Patients not receiving sevoflurane postconditioning after revascularization completed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
postoperative day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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).
participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
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.
participants will be followed for the duration of hospital stay, an expected average of 3 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hee Pyung Park, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

July 24, 2015

First Submitted That Met QC Criteria

July 26, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 26, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sevo_postconditioning

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Moyamoya Disease

Clinical Trials on Sevoflurane

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe