Sevoflurane and Hyperperfusion Syndrome

Moyamoya Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02510586
• Other study ID #: Sevo_postconditioning
• Status: Not yet recruiting
• Phase: N/A
• First received: July 24, 2015
• Last updated: July 26, 2015
• Start date: August 2015
• Est. completion date: September 2018

Study information

• Verified date: July 2015
• Source: Seoul National University Hospital
• Contact: Hee Pyung Park, MD, PhD
• Phone: 82-2-2072-2466
• Email: hppark[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 152
• Est. completion date: September 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Hyperperfusion Syndrome
• Moyamoya Disease
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The incidence of a new onset postoperative cerebral ischemia	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.	No
Secondary	The incidence of a new onset postoperative brain hematoma	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.	No
Secondary	The incidence of unrecovered neurological deficit	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.	No