Effects of Remote Ischemic Preconditioning With Postconditioning on Neurologic Outcome

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03072914

Collaborator

(none)

108

Enrollment

Location

Arms

16.3

Actual Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

108 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 :

Mar 7, 2017

Actual Primary Completion Date :

Jul 15, 2018

Actual Study Completion Date :

Jul 15, 2018

Arms and Interventions

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)

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

Outcome Measures

Primary Outcome Measures

Number of major adverse event [postoperative one month]
hyperperfusion syndrome, hypoperfusion, EDH, SAH, acute infarction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National Univ. Bundang Hospita	Seongnam-si	Gyeonggi-do	Korea, Republic of	463-707

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT03072914

Other Study ID Numbers:

B-1405/250-007

First Posted:

Mar 7, 2017

Last Update Posted:

Aug 23, 2018

Last Verified:

Mar 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Moyamoya Disease

Ischemia

Study Results

No Results Posted as of Aug 23, 2018