Effects of Remote Ischemic Preconditioning With Postconditioning on Neurologic Outcome

Overview

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

Full Title of Study: “Effects of Remote Ischemic Preconditioning With Postconditioning in Patients Undergoing Superficial Temporal Artery-middle Cerebral Artery (STA-MCA) Anastomosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 15, 2018

Interventions

  • 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)

Arms, Groups and Cohorts

  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • Number of major adverse event
    • Time Frame: postoperative one month
    • hyperperfusion syndrome, hypoperfusion, EDH, SAH, acute infarction

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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