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Effects of Remote Ischemic Preconditioning With Postconditioning on Neurologic Outcome

Primary Purpose

Moyamoya Disease, Remote Ischemic Preconditioning

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RIPC with RIPostC
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Moyamoya Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National Univ. Bundang Hospita

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

The control group

RIPC with RIPostC group

Arm Description

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.

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)

Outcomes

Primary Outcome Measures

Number of major adverse event
hyperperfusion syndrome, hypoperfusion, EDH, SAH, acute infarction

Secondary Outcome Measures

Full Information

First Posted
February 14, 2017
Last Updated
August 21, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03072914
Brief Title
Effects of Remote Ischemic Preconditioning With Postconditioning on Neurologic Outcome
Official Title
Effects of Remote Ischemic Preconditioning With Postconditioning in Patients Undergoing Superficial Temporal Artery-middle Cerebral Artery (STA-MCA) Anastomosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 7, 2017 (Actual)
Primary Completion Date
July 15, 2018 (Actual)
Study Completion Date
July 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moyamoya Disease, Remote Ischemic Preconditioning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
RIPC with RIPostC group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
RIPC with RIPostC
Intervention Description
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 Measure Information:
Title
Number of major adverse event
Description
hyperperfusion syndrome, hypoperfusion, EDH, SAH, acute infarction
Time Frame
postoperative one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists Adults 18 to 65 years of age In patients with planned MCA-STA anastomosis under general anesthesia Patients who pre-agreed to the study Exclusion Criteria: If there is a history of peripheral vascular arterial or venous disease If there is a previous history of peripheral nerve disease Other brain or cerebrovascular disease In case of serious cardiovascular disease, pulmonary disease, kidney disease Patients who do not agree with the test
Facility Information:
Facility Name
Seoul National Univ. Bundang Hospita
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Effects of Remote Ischemic Preconditioning With Postconditioning on Neurologic Outcome

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