HypotensionNCT07747441
Perfusion Index and Spinal Hypotension in Day-Case Knee Arthroscopy
An observational study of Hypotension and Spinal Anesthesia Induced Hypotension, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to investigate the role of the baseline perfusion index (PI) in predicting spinal anesthesia-induced hypotension (SAIH) in ASA I-II patients undergoing day-case knee arthroscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypotension, Spinal Anesthesia Induced Hypotension, Anesthesia, Spinal
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Aug 2026to 28 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with American Society of Anesthesiologists physical status I or II who are scheduled for elective knee arthroscopy under spinal anesthesia at Etlik City Hospital will be consecutively screened for participation.
Who may be able to join
- Between the ages of 18-65
- Having an ASA Score of I-II
- Including data collection of parts that underwent knee arthroscopy
Who cannot join
- Patients under 18 and over 65 years of age
- Patients with ASA Score III and above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Yenimahalle\Ankara, 06170
İbrahim MD Topcu, 05437860316, ibrahimtpc78@gmail.com
Musa Assoc.Prof Zengin, 00905307716235, musazengin@gmail.com
About this study
Official title: Predictive Value of Baseline Perfusion Index for Spinal Anesthesia-Induced Hypotension in Healthy Patients Undergoing Knee Arthroscopy: A Prospective Observational Trial
This prospective observational study aims to investigate the role of the baseline perfusion index (PI) in predicting spinal anesthesia-induced hypotension (SAIH) in ASA I-II patients undergoing day-case knee arthroscopy.
Spinal anesthesia is a widely preferred technique for lower extremity surgeries, including knee arthroscopy. However, sympathetic blockade during spinal anesthesia frequently leads to significant hemodynamic instability, particularly hypotension, which can result in adverse perioperative outcomes. While age and baseline blood pressure are traditional risk factors, they often fail to accurately predict the onset of hypotension in healthy populations. The perfusion index (PI), a non-invasive parameter measured via pulse oximetry, reflects peripheral vascular tone and baseline sympathetic activity. An elevated baseline PI indicates baseline vasodilation and a higher susceptibility to sympathectomy, potentially offering an early and non-invasive prediction of SAIH before the hemodynamic collapse occurs.
The primary outcome of the study is the incidence of spinal anesthesia-induced hypotension (defined as a mean arterial pressure < 65 mmHg or a decrease in systolic blood pressure > 25% from baseline). Secondary outcomes include the onset time of sensory block, and intraoperative ephedrine and fluid requirements.
- Keywords
- Perfusion Index, Spinal Anesthesia, Hypotension, Knee Arthroscopy
- Medical subject headings
- Hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal anesthesia-induced hypotension
Defined as a mean arterial pressure < 65 mmHg or a decrease in systolic blood pressure > 25% from baseline
Measured: During the surgery
Secondary outcomes (2)
Investigation of Sensory Block Kinetics
Time to reach the T10 sensory dermatome
Measured: Periprocedural
Vasopressor Consumption
Total amount of rescue vasopressor (Ephedrine) consumed to treat hypotension during the intraoperative period
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start6 Aug 2026
- Primary completion14 Dec 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İbrahim Topcu, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747441
- Sponsor's protocol ID
- AEŞH-EK-2026-171
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Baseline Perfusion Index for Spinal Anesthesia-Induced Hypotension in Healthy Patients Undergoing Knee Arthroscopy: A Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT07747441
- Acronym / sponsor ID
- AEŞH-EK-2026-171
- Keywords
- Perfusion Index, Spinal Anesthesia, Hypotension, Knee Arthroscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 5 Aug 2026 (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.
This prospective observational study aims to investigate the role of the baseline perfusion index (PI) in predicting spinal anesthesia-induced hypotension (SAIH) in ASA I-II patients undergoing day-case knee arthroscopy.
Spinal anesthesia is a widely preferred technique for lower extremity surgeries, including knee arthroscopy. However, sympathetic blockade during spinal anesthesia frequently leads to significant hemodynamic instability, particularly hypotension, which can result in adverse perioperative outcomes. While age and baseline blood pressure are traditional risk factors, they often fail to accurately predict the onset of hypotension in healthy populations. The perfusion index (PI), a non-invasive parameter measured via pulse oximetry, reflects peripheral vascular tone and baseline sympathetic activity. An elevated baseline PI indicates baseline vasodilation and a higher susceptibility to sympathectomy, potentially offering an early and non-invasive prediction of SAIH before the hemodynamic collapse occurs.
The primary outcome of the study is the incidence of spinal anesthesia-induced hypotension (defined as a mean arterial pressure < 65 mmHg or a decrease in systolic blood pressure > 25% from baseline). Secondary outcomes include the onset time of sensory block, and intraoperative ephedrine and fluid requirements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with American Society of Anesthesiologists physical status I or II who are scheduled for elective knee arthroscopy under spinal anesthesia at Etlik City Hospital will be consecutively screened for participation.
Key inclusion criteria (3 listed)
- Between the ages of 18-65
- Having an ASA Score of I-II
- Including data collection of parts that underwent knee arthroscopy
Key exclusion criteria (2 listed)
- Patients under 18 and over 65 years of age
- Patients with ASA Score III and above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spinal anesthesia-induced hypotension
Time frame: During the surgery
Defined as a mean arterial pressure < 65 mmHg or a decrease in systolic blood pressure > 25% from baseline
2 secondary outcomes
Investigation of Sensory Block Kinetics
Time frame: Periprocedural
Vasopressor Consumption
Time frame: During the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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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.
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 Hypotension and Spinal Anesthesia Induced Hypotension, run by Ankara Etlik City Hospital 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 2 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İbrahim MD Topcu, MD (05437860316, ibrahimtpc78@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal anesthesia-induced hypotension (time frame: During the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.