Regional Hemodynamic Parameter Changes After Spinal Anesthesia

NCT05332379 | Completed

• 1 other identifier: 09.2021.1406
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anesthesia is a regional anesthesia method used for surgical procedures generally involving the lower abdominal area, perineum, and lower extremities. Various tests are performed to evaluate the block level after spinal anesthesia, incluyding pinprick test, cold application, and motor examination. These tests are performed to check whether the pain, sympathetic and motor nerve fibers are affected, respectively, after the block; and good communication with the patient is important here. However, it is extremely difficult to evaluate these tests in pediatric, geriatric, mentally retarded or uncooperative patients. Sympathectomy can be used as a criterion to evaluate the success of the block that occurs after the spinal anesthesia procedure. Sympathetic nerve fibers are the first to be affected by the block, and the success of the block can be evaluated with the revealed sympathectomy. Sympathectomy in the lower extremities after spinal block increases arterial blood flow. This increase in blood flow can be detected by the Pulsed Wave Doppler feature of USG.

Conditions

Spinal Anesthesia Evaluation

Keywords

Spinal anesthesia; Test; Pulsed Wave Doppler; Sympathectomy

Outcome Measures

Primary Outcomes (1)

• Arterial velocity changes

  Posterior tibial artery velocities (peak systolic, end-diastolic) and vessel diameters will be measured after the spinal anesthesia procedure.

  At the 5th and 10th minutes after the spinal anesthesia procedure

Interventions

Pulsed Wave Doppler USG examination DIAGNOSTIC_TEST

Pulsed Wave Doppler USG examination of the posterior tibial artery on the left or right lower extremity will be performed before spinal anesthesia, at the 5th and 10th minutes after the spinal anesthesia. Blood flow velocities and vessel diameters will be measured.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective operation with spinal anesthesia will be recruited for the study. Posterior tibial artery velocities (peak systolic, end-diastolic) and the vessel diameters will be measured via USG Pulsed Wave Doppler mode. Three measurements will be performed: before spinal anesthesia, at the 5th and at the 10th minutes after the subarachnoid injection. The patients' sensory and motor examinations will be performed as well.

You may qualify if:

• Elective surgery under spinal anesthesia
• American Society of Anesthesiologists (ASA) I-II physical status

You may not qualify if:

• Contraindication for spinal anesthesia
• ASA physical status \>II
• Vasoactive drug usage

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine

Istanbul, Pendik, 34899, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 18, 2022
• Study Start: April 1, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: December 31, 2024

Record last verified: 2023-10

Locations

TU (1)