## Protocol Section
### Identification Module
**NCT ID:** NCT06427382

**Brief Title:** Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia

**Official Title:** Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia

#### Organization Study ID Info
**ID:** perfusion index
#### Organization
**Class:** OTHER
**Full Name:** Ankara City Hospital Bilkent
### Status Module
#### Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-25

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ankara City Hospital Bilkent

#### Responsible Party

**Investigator Affiliation:** Ankara Yildirim Beyazıt University

**Investigator Full Name:** Fatma Kavak Akelma

**Investigator Title:** anesthesiology and reanimation associate professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** It is aimed to investigate whether perfusion index (PI) can predict hypotension after spinal anesthesia in elderly patients as much as in young patients.

**Detailed Description:** In orthopedic lower extremity surgeries, spinal anesthesia is a preferred method of anesthesia compared to general anesthesia. Spinal anesthesia may cause severe hypotension and adverse effects in the patient due to pharmacologic sympathectomy. Especially elderly patients and patients with comorbid diseases are at risk. Hypoperfusion and vasopressor drugs to be used in treatment may lead to adverse effects.

Perfusion index is calculated as the ratio non-pulsatile to pulsatile flow in peripheral capillary blood flow. Perfusion index is a non-invasive method that provides insight into the dynamics of vascular tone using pulse oximetry. It can be used to evaluate perfusion dynamics due to changes in peripheral vascular tone and to detect the possibility of developing hypotension following spinal anesthesia. There is insufficient data to evaluate whether PI is a marker of hypotension after spinal anesthesia in older patients compared to younger patients. The planned study aims to investigate whether PI predicts hypotension after spinal anesthesia in older patients as well as young patients.

Preoperative demographic data of the patients, preoperative heart rate, noninvasive systolic, and diastolic blood pressures, mean arterial pressures, and peripheral oxygen saturations will be measured and noted. For the initial perfusion index (PI) value, PI measurements will be taken 3 times at a few minute intervals with a noninvasive probe attached to the finger, and the average will be recorded as the initial PI value. Spinal anesthesia will be applied by injecting an appropriate dose of 0.5% hyperbaric bupivacaine intrathecally, depending on the patient's structure and the type of surgery, to ensure adequate sensory and motor blockade. The patient will be immediately placed in the supine position. After the appropriate period, the level of sensory blockade will be evaluated. Heart rate, noninvasive systolic, and diastolic blood pressures, mean arterial pressure, peripheral oxygen saturation, and perfusion index will be recorded. Hypotension after spinal anesthesia will be defined as systolic blood pressure less than 90 mmHg, systolic blood pressure decrease by more than 25% from the preoperative baseline value, or average blood pressure less than 60 mmHg. Patients under the age of 60 or over the age of 60 who will undergo lower extremity surgery under spinal anesthesia will be evaluated in two groups. It will be examined whether there are differences between the groups in terms of demographic data (age, gender, comorbidity, etc.) and perfusion index.

The study's primary outcome is to investigate whether PI values have a predictive value in predicting post-spinal hypotension between the two groups and, if so, whether there is a statistically significant difference.

The secondary outcome is to evaluate whether the perfusion index can be used to predict spine-induced hypotension in orthopedic lower extremity surgery.

### Conditions Module

**Conditions:**

- Anesthesia, Spinal

**Keywords:**

- spinal anesthesia

- perfusion index

- orthopedic surgery

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients aged 65 years and older

**Intervention Names:**

- Device: Perfusion index

**Label:** group 1 (age > 65 years)

#### Arm Group 2

**Description:** Patients aged 18 to 65 years

**Intervention Names:**

- Device: Perfusion index

**Label:** group 2 (age < 65 years)

### Interventions

#### Intervention 1

**Arm Group Labels:**

- group 1 (age > 65 years)

- group 2 (age < 65 years)

**Description:** Perfusion index determination using non-invasive pulse oximetry

**Name:** Perfusion index

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Determine a threshold for baseline PI value using logistic regression analysis to predict hypotension after spinal anesthesia

**Measure:** Perfusion index age difference

**Time Frame:** 1 hours

#### Secondary Outcomes

**Description:** Determining baseline perfusion index threshold to predict possible hypotension after spinal anesthesia

**Measure:** Perfusion index cut-off point

**Time Frame:** 1 hours

**Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure

**Measure:** Systolic blood pressure

**Time Frame:** 1 hours

**Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure

**Measure:** Diastolic blood pressure

**Time Frame:** 1 hours

**Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure

**Measure:** Mean arterial pressure

**Time Frame:** 1 hours

**Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure

**Measure:** Hearth Rate

**Time Frame:** 1 hours

**Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure

**Measure:** perfusion index

**Time Frame:** 1 hours

**Description:** recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure

**Measure:** oxygen saturation(SpO2)

**Time Frame:** 1 hours

**Description:** time to reach the bromage 3 score

**Measure:** bromage score

**Time Frame:** 1 hours

**Description:** time to reach t10 dermatome level

**Measure:** T10 dermatome

**Time Frame:** 1 hours

**Description:** the highest dermatome level achieved with spinal anesthesia

**Measure:** dermatomal level

**Time Frame:** 1 hours

**Description:** ephedrine use

**Measure:** use ephedrine

**Time Frame:** 24 hours

**Description:** To study side effects between 2 groups

**Measure:** side effects

**Time Frame:** 24 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-II-III physical status
* patients planned for effective lower extremity surgery in the supine position
* age \>18 years

Exclusion Criteria:

* Known cardiac abnormalities (left ventricular ejection fraction \<50% or decompensated heart failure, heart block, arrhythmia)
* uncontrolled hypertension
* hyperthyroidism
* monoamine oxidase inhibitor use
* chronic beta-blocker or digoxin therapy
* severe arrhythmia
* peripheral arterial disease
* history of glaucoma
* hepatic cell failure
* renal failure
* local anesthetic allergy
* contraindications for spinal anesthesia

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** patients admitted to ankara city hospital for lower extremity surgery in supine position

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** fatmakavak@yahoo.com

**Name:** Fatma K Akelma

**Phone:** 05327079113

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10072

- Name: Hypotension

- Relevance: HIGH

- As Found: Hypotension

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007022

- Term: Hypotension

### 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: 2024-05-31
