Changes in the Microvascular Reactivity on Leg During Spinal Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia
• Intervention / Treatment: Diagnostic test: Vascular occlusion test

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.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hopsital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

adult patients, 18<age< 60 years old, scheduled for spinal anesthesia

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of recovery slope between baseline and 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	baseline and immediately after spinal anesthesia

Collaborators and Investigators

• Sponsor: Pusan National University Hospital
• Investigators: Principal Investigator: Hyae-Jin Kim, PhD, Pusan National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 29, 2016
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (ACTUAL): March 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Spinal anesthesia; Microvascular Circulation; Spectroscopy, near-infrared
• Other Study ID Numbers: No. H-1611-016-048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes