Spinal AnesthesiaFQRS-TKANCT07112313
Frontal QRS Axis Changes in Patients Undergoing Total Knee Arthroplasty With Spinal Anesthesia (FQRS-TKA)
An observational study of Spinal Anesthesia and Total Knee Arthroplasty, run by Sevim Şenol Karataş at 1 site in Turkey (Türkiye).
Trial summary
This prospective, single-center, observational study aims to evaluate changes in the frontal QRS axis on ECG before and after spinal anesthesia in patients undergoing total knee arthroplasty. The primary objective is to determine whether spinal anesthesia causes a significant alteration in the frontal QRS axis. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Spinal Anesthesia, Total Knee Arthroplasty
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Oct 2025
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 45-85 years undergoing elective total knee arthroplasty under spinal anesthesia at Elazığ Fethi Sekin City Hospital.
Who may be able to join
- Aged between 45 and 85 years
- ASA physical status I-III
- Scheduled for elective total knee arthroplasty under spinal anesthesia
- Able to tolerate 12-lead ECG before and within 2 hours after surgery
Who cannot join
- Known rhythm disorders affecting ECG axis (e.g., heart block, atrial fibrillation, pacemaker)
- Conversion to general anesthesia
- Admission to intensive care unit after surgery
- Missing ECG data
- Communication or mental disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Elazığ Fethi Sekin City Hospital
Elâzığ, Merkez, 23200
About this study
Official title: A Prospective, Observational, Single-Center Study Evaluating Preoperative and Postoperative Changes in the Frontal QRS Axis on Electrocardiogram in Patients Undergoing Total Knee Arthroplasty Under Spinal Anesthesia
This prospective, single-center, observational study aims to evaluate changes in the frontal QRS axis on ECG before and after spinal anesthesia in patients undergoing total knee arthroplasty. The primary objective is to determine whether spinal anesthesia causes a significant alteration in the frontal QRS axis. A total of 80 patients will be enrolled, and preoperative and postoperative ECG measurements will be compared using paired t-test or Wilcoxon signed-rank test depending on data distribution.
Read the detailed description
This study will be conducted in the Department of Anesthesiology and Reanimation at Elazığ Fethi Sekin City Hospital. It is a prospective, observational, and single-center study designed to evaluate the impact of spinal anesthesia on the frontal QRS axis in patients undergoing elective total knee arthroplasty.
The primary endpoint is the difference between preoperative and postoperative frontal QRS axis measurements. ECG recordings will be taken within 2 hours before and after surgery. Frontal QRS axis values will be automatically calculated by the ECG machine and verified manually.
Inclusion criteria include patients aged 45-85 years, ASA class I-III, undergoing spinal anesthesia for elective knee replacement surgery, and able to obtain ECG recordings before and after the procedure. Patients with arrhythmias such as atrial fibrillation or pacemaker dependency, or those requiring postoperative ICU care or general anesthesia conversion will be excluded.
The estimated sample size was calculated using G*Power software. Based on previous studies, a minimum of 34 patients is required to detect a clinically significant change of 10 degrees in QRS axis, with a planned enrollment of 80 patients considering data loss.
Statistical analysis will be conducted using SPSS 26.0. A p-value <0.05 will be considered statistically significant.
- Conditions
- Spinal Anesthesia, Total Knee Arthroplasty
- Keywords
- Frontal QRS axis, Spinal anesthesia, Total knee replacement, Electrocardiogram (ECG), Postoperative ECG changes, Regional anesthesia, Orthopedic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TKA Patients | Patients undergoing elective total knee arthroplasty under spinal anesthesia. Frontal QRS axis will be measured using standard 12-lead ECG preoperatively (within 2 hours before surgery) and postoperatively (within 2 hours after surgery and before mobilization). The study aims to evaluate the change in frontal QRS angle following spinal anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Frontal QRS Axis After Spinal Anesthesia
To evaluate the difference in frontal QRS axis values on the electrocardiogram (ECG) before and after spinal anesthesia in patients undergoing total knee arthroplasty.
Measured: From 2 hours before to 2 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sevim Şenol Karataş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
- Investigators
- Sevim Ş Karataş, MD, Principal investigator, Elazığ Fethi Sekin City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112313
- Sponsor's protocol ID
- EFSH-ANES-2025-01
- Acronym
- FQRS-TKA
- Status last verified
- Nov 2025
- First submitted
- 1 Aug 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Single-Center Study Evaluating Preoperative and Postoperative Changes in the Frontal QRS Axis on Electrocardiogram in Patients Undergoing Total Knee Arthroplasty Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07112313
- Acronym / sponsor ID
- FQRS-TKA / EFSH-ANES-2025-01
- Conditions
- Spinal Anesthesia, Total Knee Arthroplasty
- Keywords
- Frontal QRS axis, Spinal anesthesia, Total knee replacement, Electrocardiogram (ECG), Postoperative ECG changes, Regional anesthesia, Orthopedic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sevim Şenol KarataşUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 8 Aug 2025 (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, single-center, observational study aims to evaluate changes in the frontal QRS axis on ECG before and after spinal anesthesia in patients undergoing total knee arthroplasty. The primary objective is to determine whether spinal anesthesia causes a significant alteration in the frontal QRS axis. A total of 80 patients will be enrolled, and preoperative and postoperative ECG measurements will be compared using paired t-test or Wilcoxon signed-rank test depending on data distribution.
Detailed description
This study will be conducted in the Department of Anesthesiology and Reanimation at Elazığ Fethi Sekin City Hospital. It is a prospective, observational, and single-center study designed to evaluate the impact of spinal anesthesia on the frontal QRS axis in patients undergoing elective total knee arthroplasty.
The primary endpoint is the difference between preoperative and postoperative frontal QRS axis measurements. ECG recordings will be taken within 2 hours before and after surgery. Frontal QRS axis values will be automatically calculated by the ECG machine and verified manually.
Inclusion criteria include patients aged 45-85 years, ASA class I-III, undergoing spinal anesthesia for elective knee replacement surgery, and able to obtain ECG recordings before and after the procedure. Patients with arrhythmias such as atrial fibrillation or pacemaker dependency, or those requiring postoperative ICU care or general anesthesia conversion will be excluded.
The estimated sample size was calculated using G*Power software. Based on previous studies, a minimum of 34 patients is required to detect a clinically significant change of 10 degrees in QRS axis, with a planned enrollment of 80 patients considering data loss.
Statistical analysis will be conducted using SPSS 26.0. A p-value <0.05 will be considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TKA Patients | – | –Patients undergoing elective total knee arthroplasty under spinal anesthesia. Frontal QRS axis will be measured using standard 12-lead ECG preoperatively (within 2 hours before surgery) and postoperatively (within 2 hours after surgery and before mobilization). The study aims to evaluate the change in frontal QRS angle following spinal anesthesia. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 45-85 years undergoing elective total knee arthroplasty under spinal anesthesia at Elazığ Fethi Sekin City Hospital.
Key inclusion criteria (4 listed)
- Aged between 45 and 85 years
- ASA physical status I-III
- Scheduled for elective total knee arthroplasty under spinal anesthesia
- Able to tolerate 12-lead ECG before and within 2 hours after surgery
Key exclusion criteria (5 listed)
- Known rhythm disorders affecting ECG axis (e.g., heart block, atrial fibrillation, pacemaker)
- Conversion to general anesthesia
- Admission to intensive care unit after surgery
- Missing ECG data
- Communication or mental disorders
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
Change in Frontal QRS Axis After Spinal Anesthesia
Time frame: From 2 hours before to 2 hours after surgery
To evaluate the difference in frontal QRS axis values on the electrocardiogram (ECG) before and after spinal anesthesia in patients undergoing total knee arthroplasty.
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 3 Dec 2025.
- 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.
Sevim Ş Karataş, MD principal investigator
Elazığ Fethi Sekin City Hospital
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 Spinal Anesthesia and Total Knee Arthroplasty, run by Sevim Şenol Karataş 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 4 inclusion and 5 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 3 Dec 2025. 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?
Change in Frontal QRS Axis After Spinal Anesthesia (time frame: From 2 hours before to 2 hours after 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 3 Dec 2025.