Changes in the Microvascular Reactivity on Leg During Spinal Anesthesia
NCT ID: NCT04806997
Last Updated: 2021-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
51 participants
OBSERVATIONAL
2016-12-29
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Vascular occlusion test
The VOT procedure was conducted twice in each patient, before and 15 min after intrathecal injection. An NIRS sensor (INVOSTM 5100C Cerebral/Somatic Oximeter; Medtronic, Minneapolis, MN, USA) was attached to the patient's gastrocnemius muscle. A tourniquet (A.T.S ® 3000 Automatic Tourniquet System; Zimmer Inc., Warsaw, IL, USA) was applied to the thigh and inflated to a pressure value 50 mmHg over the patient's baseline systolic blood pressure in the leg and maintained for 5 min. After a 5-min ischemic period, the tourniquet was rapidly deflated to 0 mmHg. The StO2 data was continuously recorded during the VOT procedure. After confirmation of spinal anesthesia using cold sensitivity, the VOT procedure was repeated in the same manner as mentioned above. The occlusion slope and recovery slope were calculated based on the measured StO2 data.
Eligibility Criteria
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Inclusion Criteria
* 18\< age \< 60 years old
Exclusion Criteria
* allergy or sensitivity to study medications,
* alcohol or drug abuse history,
* body mass index \> 35 kg/ m2 or \< 15 kg/m2,
* p regnancy or breastfeeding status,
* diabetes and on insulin treatment,
* untreated or uncontrolled arterial hypertension,
* peripheral arterial disease,
* corticosteroid treatment, coagulopathy, and lower limb deformities or burns
* patients who may not tolerate VOT
18 Years
60 Years
ALL
No
Sponsors
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Pusan National University Hospital
OTHER
Responsible Party
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Hyae-Jin Kim
Associate professor
Principal Investigators
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Hyae-Jin Kim, PhD
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Hospital
Locations
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Pusan National University Hopsital
Busan, , South Korea
Countries
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Other Identifiers
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No. H-1611-016-048
Identifier Type: -
Identifier Source: org_study_id
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