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Effects of Remote Ischemic Preconditioning With Postconditioning on Neurologic Outcome

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ClinicalTrials.gov Identifier: NCT03072914
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:
In the present study, we evaluated whether RIPC with RIPostC reduce the major neurocomplication in patients undergoing STA-MCA anastomosis.

Condition or disease Intervention/treatment Phase
Moyamoya Disease Remote Ischemic Preconditioning Procedure: RIPC with RIPostC Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Remote Ischemic Preconditioning With Postconditioning in Patients Undergoing Superficial Temporal Artery-middle Cerebral Artery (STA-MCA) Anastomosis
Actual Study Start Date : June 2014
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: The control group
The control group has a sphygmomanometer wound around the upper arm or lower extremity and applies the same pressure, but a 3-way stopcock is installed in the middle so that no pressure is applied.
Active Comparator: RIPC with RIPostC group
The sphygmomanometer is closed to the lower limb and the cuff is inflated and the pressure is increased by 30 mmHg higher than the systolic blood pressure of each patient for 5 minutes. The loss of the distal pulse is confirmed by Doppler in the dorsalis pedis pulse. If there is a pulse, increase the pressure until it disappears. After 5 minutes of ischemia time, the cuff is deflated to confirm that the pulse has returned and has a reperfusion time of 5 minutes. A total of 4 cycles of 5 cycles of ischemic time and 5 minutes of reperfusion time are performed. (Estimated total 40 minutes) When the skull is started to close, RIpc with RIPostC group performs RpostC and the method is the same as the above RIPC method. (Estimated total 40 minutes)
Procedure: RIPC with RIPostC
The sphygmomanometer is closed to the lower limb and the cuff is inflated and the pressure is increased by 30 mmHg higher than the systolic blood pressure of each patient for 5 minutes. The loss of the distal pulse is confirmed by Doppler in the dorsalis pedis pulse. If there is a pulse, increase the pressure until it disappears. After 5 minutes of ischemia time, the cuff is deflated to confirm that the pulse has returned and has a reperfusion time of 5 minutes. A total of 4 cycles of 5 cycles of ischemic time and 5 minutes of reperfusion time are performed. (Estimated total 40 minutes) When the skull is started to close, RIpc with RIPostC group performs RpostC and the method is the same as the above RIPC method. (Estimated total 40 minutes)




Primary Outcome Measures :
  1. Number of major adverse event [ Time Frame: postoperative one month ]
    hyperperfusion syndrome, hypoperfusion, EDH, SAH, acute infarction



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. American Society of Anesthesiologists
  2. Adults 18 to 65 years of age
  3. In patients with planned MCA-STA anastomosis under general anesthesia
  4. Patients who pre-agreed to the study

Exclusion Criteria:

  1. If there is a history of peripheral vascular arterial or venous disease
  2. If there is a previous history of peripheral nerve disease
  3. Other brain or cerebrovascular disease
  4. In case of serious cardiovascular disease, pulmonary disease, kidney disease
  5. Patients who do not agree with the test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072914


Locations
Korea, Republic of
Seoul National Univ. Bundang Hospita
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03072914     History of Changes
Other Study ID Numbers: B-1405/250-007
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Ischemia
Moyamoya Disease
Pathologic Processes
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases