Examination of The Relationshıp Between Body Mass Index And The Skin-Epidural Space Distance

Anesthesia Awareness Clinical Trial

Official title:

Examination of the Relationship Between Body Mass Index and the Skin-epidural Space Distance Measured by Ultrasound in the Lumbar Region

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06316622
• Other study ID #: 2021/08/42
• Status: Completed
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: March 2024
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: The aim of the study; to investigate whether there is a relationship between body mass index (BMI), waist circumference, and abdominal subcutaneous adipose tissue and the skin-epidural space distance measured by USG.

Description:

The research was carried out in the block room in the preoperating room of Dokuz Eylül University Practice and Research Hospital and with 42 volunteer operating room workers aged between 18-59 years. Height, weight and waist circumference measurements were made with standard measuring instruments, and other measurements were completed by ultrasonography (USG) separately by an anesthesiologist and a radiologist. For ultrasonographic evaluation, left lateral decubitus, right lateral decubitus and in sitting position, skin-dural junction, skin-vertebra corpus, anterior complex distances, upper and lower SIAS levels were examined with convex probe as transverse median. In addition, abdominal subcutaneous fat thickness measurements were made with a linear probe in the supine position. The statistical correlations of all measurements were examined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 58 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 59 years old.

2. ASA I-II classification.

3. Body Mass Index (BMI): 18.5-29.9 kg/m2.

Exclusion Criteria:

1. Individuals under 18 or over 59 years old.

2. Those with a history of vertebral surgery.

3. Patients diagnosed with spinal deformities (excluding scoliosis =10 degrees, kyphosis <30 or >80 degrees).

4. Individuals with rheumatologic diseases affecting skeletal structure such as ankylosing spondylitis, rheumatoid arthritis.

5. Presence of wounds or infections in the lumbar region.

6. Volunteers who underwent epidural or spinal interventions in the lumbar region within the last month.

7. Individuals with bone implants affecting posture, such as hip or knee prostheses.

8. Pregnant women.

9. Individuals with conditions like Cushing's syndrome, hypothyroidism, acromegaly causing lumbar edema.

10. Volunteers using corticosteroids.

11. Obese individuals (BMI: >29.9).

Related Conditions & MeSH terms

• Anesthesia Awareness
• Intraoperative Awareness

Intervention

Device:
• ultrasound
measured by ultrasound

Locations

Country	Name	City	State
Turkey	Dokuz Eylul Unicersity	Izmir	Narlidere
Turkey	Dokuz Eylul University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	We examined the relationships between body mass index calculated by measuring weight and height, subcutaneous fat tissue in the abdominal region and the skin-epidural space distance in the lumbar region; measured by ultrasound.	Unexpectedly low skin-epidural space distances can be seen even in individuals with high weight and fat content.; For the targeted space between above the anterior superior iliac spine (ASIS) (estimated L3-L4) and below the ASIS, each patient was positioned in the left lateral, right lateral and then sitting positions, with a transverse-median approach performed by an anaesthetist followed by a radiologist. Skin-dural composite (SDC), skin-vertebral body and anterior complex (posterior longitudinal ligament) distance measurements were recorded separately. Subcutaneous abdominal fat thickness was measured using a linear probe of an ultrasound device (LOGIQ-E, GE Medical Systems, China) to ensure consistency. Measurements were taken at two points (right lateral, left lateral) 2 cm away from the umbilicus and recorded by averaging. Waist circumference was measured using a standard measuring tape at the navel level in all volunteers.	six months