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Anesthesia, SpinalNCT06427382

Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia

An observational study of Anesthesia, Spinal, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It is aimed to investigate whether the perfusion index (PI) can predict hypotension after spinal anesthesia in elderly patients as much as in non-elderly patients. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Anesthesia, Spinal
What is being tested?
Perfusion index
Type of treatment
Medical device
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 May 2024to 1 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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
Show all 12Show fewer
  • peripheral arterial disease
  • history of glaucoma
  • hepatic cell failure
  • renal failure
  • local anesthetic allergy
  • contraindications for spinal anesthesia

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Bilkent City Hospital

    Ankara, Ankara, Çankaya,, 06800

Other trials in Turkey (Türkiye)

About this study

It is aimed to investigate whether the perfusion index (PI) can predict hypotension after spinal anesthesia in elderly patients as much as in non-elderly patients.

Read the 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 assess whether PI is a marker of hypotension after spinal anesthesia in older patients compared to non-elderly patients. The planned study aims to investigate whether PI predicts hypotension after spinal anesthesia in older patients as well as non-elderly 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 is 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 65 or over the age of 65 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\&amp;#39;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.

Being tested
Perfusion index
Keywords
spinal anesthesia, perfusion index, orthopedic surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Perfusion indexDevice

    Perfusion index determination using non-invasive pulse oximetry

Study groups in NCT06427382
Study groupRoleWhat they receive
group E (age > 65 years)Patients aged 65 years and older
Receives: Device: Perfusion index
group N (age < 65 years)Patients aged 18 to 65 years
Receives: Device: Perfusion index

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perfusion index age difference

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

    Measured: 1 hours

Secondary outcomes (12)
  1. Perfusion index cut-off point

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

    Measured: 1 hours

  2. Systolic blood pressure

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

    Measured: 1 hours

  3. Diastolic blood pressure

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

    Measured: 1 hours

  4. Mean arterial pressure

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

    Measured: 1 hours

  5. Hearth Rate

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

    Measured: 1 hours

  6. perfusion index

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

    Measured: 1 hours

  7. oxygen saturation(SpO2)

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

    Measured: 1 hours

  8. bromage score

    time to reach the bromage 3 score

    Measured: 1 hours

  9. T10 dermatome

    time to reach t10 dermatome level

    Measured: 1 hours

  10. dermatomal level

    the highest dermatome level achieved with spinal anesthesia

    Measured: 1 hours

  11. use ephedrine

    ephedrine use

    Measured: 24 hours

  12. side effects

    To study side effects between 2 groups

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2024
  2. Study start25 May 2024
  3. Primary completion15 Aug 2024
  4. Study completion1 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06427382
Sponsor's protocol ID
perfusion index
Status last verified
Oct 2024
First submitted
19 May 2024
Last updated
22 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kavak Akelma F, Mafizer M, Nalbant B. Perfusion index as a predictor of hypotension after spinal anesthesia in lower extremity orthopedic surgery: a prospective observational trial. BMC Surg. 2025 Aug 7;25(1):348. doi: 10.1186/s12893-025-03036-y.

    PubMed 40770325

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, Spinal, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perfusion index age difference (time frame: 1 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06427382, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.

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