Changes in the Microvascular Reactivity on Leg During Spinal Anesthesia

NCT04806997 | Completed FDA Drug FDA Device

• 1 other identifier: No. H-1611-016-048
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia

Keywords

Microvascular Circulation; Spectroscopy, near-infrared; Spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Vascular occlusion test DIAGNOSTIC_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

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University Hopsital

Busan, 49241, South Korea

Location

Study Officials

• Hyae-Jin Kim, PhD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 19, 2021
• Study Start: December 29, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 19, 2021

Record last verified: 2021-03

Locations

KR (1)