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Clinical Trials/NCT04806997
NCT04806997
Completed
Not Applicable

Changes in the Microvascular Reactivity on Leg During Spinal Anesthesia

Pusan National University Hospital1 site in 1 country51 target enrollmentDecember 29, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Anesthesia
Sponsor
Pusan National University Hospital
Enrollment
51
Locations
1
Primary Endpoint
Change of recovery slope between baseline and after spinal anesthesia
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Anesthesia alters microcirculation and tissue oxygen saturation (StO2). We sought to examine changes in StO2 using near-infrared spectroscopy and a vascular occlusion test (VOT) during spinal anesthesia. This prospective observational study was included 51 patients without comorbidities who underwent elective surgery under spinal anesthesia. We measured the StO2 in the lower extremity during VOT before and after intrathecal injection.

Detailed Description

The vascular occlusion test (VOT) procedure was conducted twice in each patient, before and 15 min after intrathecal injection. An near-infrared spectroscopy (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 tissue oxygen saturation (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. The occlusion slope was defined as the descending slope of StO2 value until it reached the minimum value. The recovery slope was calculated from the deflation of the tourniquet until the recovery of StO2 to the maximum value.

Registry
clinicaltrials.gov
Start Date
December 29, 2016
End Date
December 31, 2017
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyae-Jin Kim

Associate professor

Pusan National University Hospital

Eligibility Criteria

Inclusion Criteria

  • The patients who were scheduled for spinal anesthesia
  • 18\< age \< 60 years old

Exclusion Criteria

  • American Society of Anesthesiologists physical status class \> III,
  • 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

Outcomes

Primary Outcomes

Change of recovery slope between baseline and after spinal anesthesia

Time Frame: baseline and immediately after spinal anesthesia

Recovery slope is related to microvascular reactivity, was calculated from the deflation of the tourniquet until the recovery of tissue oxygen saturation to the highest value

Study Sites (1)

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