Hyperperfusion SyndromeNCT02510586
Sevoflurane and Hyperperfusion Syndrome
A study testing Sevoflurane in people with Hyperperfusion Syndrome and Moyamoya Disease, run by Seoul National University Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperperfusion Syndrome, Moyamoya Disease
- What is being tested?
- Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients receiving cerebral revascularization surgery due to moyamoya disease
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperperfusion Syndrome, Moyamoya Disease
- Being tested
- Sevoflurane
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevorane
administer 1.0 MAC (1.7~2.0 vol%) of sevoflurane for 30 minutes after vascular anastomosis completed
| Study group | Role | What they receive |
|---|---|---|
| Sevo_postconditioning | Experimental | Patients receiving sevoflurane 1.0 minimum alveolar concentration (MAC) for 30 minutes after revascularization competed. Receives: Drug: Sevoflurane |
| Non_postconditioning | No intervention | Patients not receiving sevoflurane postconditioning after revascularization completed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative day 15
Secondary outcomes (3)
The incidence of a new onset postoperative cerebral ischemia
cerebral ischemia is diagnosed by clinical symptoms and radiologic imaging (CT or MRI).
Measured: 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
postoperative brain hematoma is diagnosed by clinical symptoms and radiologic imaging (CT or MRI).
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
The incidence of unrecovered neurological deficit
the incidence of postoperative neurological symptoms which persisted or not fully recovered until the patient's discharge.
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hyperperfusion SyndromeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Pyoung Park, Seoul National University Hospital
- Investigators
- Hee Pyung Park, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510586
- Sponsor's protocol ID
- Sevo_postconditioning
- Status last verified
- Jul 2015
- First submitted
- 24 Jul 2015
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15713266Ishii 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.
PubMed 19953378Kim 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.
PubMed 16302615
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sevoflurane-induced Postconditioning on the Incidence of Postoperative Cerebral Hyperperfusion Syndrome After Revascularization Surgery in Adult Patients With Moyamoya Disease
- ClinicalTrials.gov ID
- NCT02510586
- Acronym / sponsor ID
- Sevo_postconditioning
- Conditions
- Hyperperfusion Syndrome, Moyamoya Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevo_postconditioning | Experimental | Drug: SevofluranePatients receiving sevoflurane 1.0 minimum alveolar concentration (MAC) for 30 minutes after revascularization competed. |
| Non_postconditioning | No intervention | –Patients not receiving sevoflurane postconditioning after revascularization completed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients receiving cerebral revascularization surgery due to moyamoya disease
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneAlso: Sevoraneadminister 1.0 MAC (1.7~2.0 vol%) of sevoflurane for 30 minutes after vascular anastomosis completed | Drug | Sevo_postconditioning |
Primary outcome
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.
3 secondary outcomes
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.
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.
The incidence of unrecovered neurological deficit
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Background: PubMed 15713266Payne 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.
- Background: PubMed 19953378Ishii 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.
- Background: PubMed 16302615Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Pyung Park, MD, PhD principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane in people with Hyperperfusion Syndrome and Moyamoya Disease, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee Pyung Park, MD, PhD (82-2-2072-2466, hppark@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative cerebral hyperperfusion syndrome (time frame: postoperative day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02510586, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015; AzTrials last refreshed its copy on 28 Oct 2026.