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).
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
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\&#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.
- Conditions
- Anesthesia, Spinal
- 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 group | Role | What 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.
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)
Perfusion index cut-off point
Determining baseline perfusion index threshold to predict possible hypotension after spinal anesthesia
Measured: 1 hours
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
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
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
Hearth Rate
recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure
Measured: 1 hours
perfusion index
recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the end of the procedure
Measured: 1 hours
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
bromage score
time to reach the bromage 3 score
Measured: 1 hours
T10 dermatome
time to reach t10 dermatome level
Measured: 1 hours
dermatomal level
the highest dermatome level achieved with spinal anesthesia
Measured: 1 hours
use ephedrine
ephedrine use
Measured: 24 hours
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.
- First posted23 May 2024
- Study start25 May 2024
- Primary completion15 Aug 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Kavak Akelma, Ankara Yildirim Beyazıt University
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT06427382
- Acronym / sponsor ID
- perfusion index
- Conditions
- Anesthesia, Spinal
- Keywords
- spinal anesthesia, perfusion index, orthopedic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 25 May 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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\&#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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group E (age > 65 years) | – | Device: Perfusion indexPatients aged 65 years and older |
| group N (age < 65 years) | – | Device: Perfusion indexPatients aged 18 to 65 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to ankara city hospital for lower extremity surgery in supine position
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) I-II-III physical status
- patients planned for effective lower extremity surgery in the supine position
- age >18 years
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perfusion indexPerfusion index determination using non-invasive pulse oximetry | Device | group E (age > 65 years), group N (age < 65 years) |
Primary outcome
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
12 secondary outcomes
Perfusion index cut-off point
Time frame: 1 hours
Systolic blood pressure
Time frame: 1 hours
Diastolic blood pressure
Time frame: 1 hours
Mean arterial pressure
Time frame: 1 hours
Hearth Rate
Time frame: 1 hours
perfusion index
Time frame: 1 hours
oxygen saturation(SpO2)
Time frame: 1 hours
bromage score
Time frame: 1 hours
T10 dermatome
Time frame: 1 hours
dermatomal level
Time frame: 1 hours
use ephedrine
Time frame: 24 hours
side effects
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Derived from this study: PubMed 40770325Kavak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.