Effects of Remote Ischemic Preconditioning With Postconditioning on Neurologic Outcome

Moyamoya Disease Clinical Trial

Official title:

Effects of Remote Ischemic Preconditioning With Postconditioning in Patients Undergoing Superficial Temporal Artery-middle Cerebral Artery (STA-MCA) Anastomosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03072914
• Other study ID #: B-1405/250-007
• Status: Completed
• Phase: N/A
• Start date: March 7, 2017
• Est. completion date: July 15, 2018

Study information

• Verified date: March 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 15, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Moyamoya Disease
• Remote Ischemic Preconditioning

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univ. Bundang Hospita	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of major adverse event	hyperperfusion syndrome, hypoperfusion, EDH, SAH, acute infarction	postoperative one month