Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia

Anesthesia, Spinal Clinical Trial

Official title:

Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427382
• Other study ID #: perfusion index
• Status: Not yet recruiting
• Start date: May 25, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: Ankara City Hospital Bilkent
• Contact: Fatma K Akelma
• Phone: 05327079113
• Email: fatmakavak[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 1, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Hypotension

Intervention

Device:
• Perfusion index
Perfusion index determination using non-invasive pulse oximetry

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfusion index age difference	Determine a threshold for baseline PI value using logistic regression analysis to predict hypotension after spinal anesthesia	1 hours
Secondary	Perfusion index cut-off point	Determining baseline perfusion index threshold to predict possible hypotension after spinal anesthesia	1 hours
Secondary	Systolic blood pressure	recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure	1 hours
Secondary	Diastolic blood pressure	recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure	1 hours
Secondary	Mean arterial pressure	recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure	1 hours
Secondary	Hearth Rate	recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure	1 hours
Secondary	perfusion index	recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure	1 hours
Secondary	oxygen saturation(SpO2)	recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure	1 hours
Secondary	bromage score	time to reach the bromage 3 score	1 hours
Secondary	T10 dermatome	time to reach t10 dermatome level	1 hours
Secondary	dermatomal level	the highest dermatome level achieved with spinal anesthesia	1 hours
Secondary	use ephedrine	ephedrine use	24 hours
Secondary	side effects	To study side effects between 2 groups	24 hours