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NCT Number: NCT06427382

Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, Ankara, Çankaya,, 06800, Turkey (Türkiye)

About this study

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'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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

perfusion index

Device

Perfusion index determination using non-invasive pulse oximetry

Primary outcomes

  1. Perfusion index age difference

    Time frame: 1 hours

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

Secondary outcomes

  1. Perfusion index cut-off point

    Time frame: 1 hours

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

  2. Systolic blood pressure

    Time frame: 1 hours

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

  3. Diastolic blood pressure

    Time frame: 1 hours

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

  4. Mean arterial pressure

    Time frame: 1 hours

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

  5. Hearth Rate

    Time frame: 1 hours

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

  6. perfusion index

    Time frame: 1 hours

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

  7. oxygen saturation(SpO2)

    Time frame: 1 hours

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

  8. bromage score

    Time frame: 1 hours

    time to reach the bromage 3 score

  9. T10 dermatome

    Time frame: 1 hours

    time to reach t10 dermatome level

  10. dermatomal level

    Time frame: 1 hours

    the highest dermatome level achieved with spinal anesthesia

  11. use ephedrine

    Time frame: 24 hours

    ephedrine use

  12. side effects

    Time frame: 24 hours

    To study side effects between 2 groups

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 23, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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