Effects of Remote Ischemic Preconditioning With Postconditioning on Neurologic Outcome

NCT03072914 | Completed

• 1 other identifier: B-1405/250-007
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Moyamoya Disease; Remote Ischemic Preconditioning

Outcome Measures

Primary Outcomes (1)

• Number of major adverse event

  hyperperfusion syndrome, hypoperfusion, EDH, SAH, acute infarction

  postoperative one month

Study Arms (2)

The control group

NO INTERVENTION

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.

RIPC with RIPostC group

ACTIVE COMPARATOR

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

Interventions

RIPC with RIPostC PROCEDURE

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)

RIPC with RIPostC group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National Univ. Bundang Hospita

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Moyamoya Disease

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: March 7, 2017
• Study Start: March 7, 2017
• Primary Completion: July 15, 2018
• Study Completion: July 15, 2018
• Last Updated: August 23, 2018

Record last verified: 2018-03

Locations

KR (1)