## Protocol Section
### Identification Module
**NCT ID:** NCT05332379

**Brief Title:** Regional Hemodynamic Parameter Changes After Spinal Anesthesia

**Official Title:** Measurement of Regional Hemodynamic Parameters Before and After Spinal Anesthesia With Doppler USG

#### Organization Study ID Info
**ID:** 09.2021.1406
#### Organization
**Class:** OTHER
**Full Name:** Marmara University
### Status Module
#### Completion Date
**Date:** 2023-07-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-18

**Type:** ACTUAL

**Last Update Submit Date:** 2023-10-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-07-20

**Type:** ACTUAL

#### Start Date
**Date:** 2022-04-01

**Type:** ACTUAL

**Status Verified Date:** 2023-10

#### Study First Post Date
**Date:** 2022-04-18
**Type:** ACTUAL
**Study First Submit Date:** 2022-04-11
**Study First Submit QC Date:** 2022-04-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Marmara University

#### Responsible Party

**Investigator Affiliation:** Marmara University

**Investigator Full Name:** Ruslan Abdullayev

**Investigator Title:** Assist. Prof.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Spinal Anesthesia Evaluation

**Keywords:**

- Spinal anesthesia

- Test

- Pulsed Wave Doppler

- Sympathectomy

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 35

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** 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.

**Name:** Pulsed Wave Doppler USG examination

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Arterial velocity changes

**Time Frame:** At the 5th and 10th minutes after the spinal anesthesia procedure

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Marmara University School of Medicine

**State:** Pendik

**Zip:** 34899

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
