Clinical trial NCT04806997: Changes in the Microvascular Reactivity on Leg During Spinal Anesthesia
Official title: Changes in the Microvascular Reactivity on Leg During Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Anesthesia
Keywords: Microvascular Circulation
Spectroscopy, near-infrared
Spinal anesthesia
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients, 18\<age\< 60 years old, scheduled for spinal anesthesia

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.

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

Primary outcomes:
measure: Change of recovery slope between baseline and after spinal anesthesia
timeFrame: baseline and immediately after spinal anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hopsital
Study officials:
affiliation: Pusan National University Hospital
name: Hyae-Jin Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: