Total Knee ArthroplastyTDP-QRSNCT07551648
Effect of Spinal and General Anesthesia on Frontal QRS Axis in Patients Undergoing Total Knee Arthroplasty
An observational study of Total Knee Arthroplasty and Electrocardiographic Changes, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to compare the effects of spinal and general anesthesia on frontal QRS axis in patients undergoing elective total knee arthroplasty. Adult patients aged 18 years and older with ASA physical status I to III will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Electrocardiographic Changes
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Sep 2025to 10 Mar 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective total knee arthroplasty at a single center and managed with either spinal anesthesia or general anesthesia in routine clinical practice.
Who may be able to join
- Adults aged 18 years and older
- Patients scheduled for elective total knee arthroplasty
- ASA physical status I to III
- Patients undergoing surgery under spinal anesthesia or general anesthesia
Who cannot join
- Presence of a pacemaker
- Known cardiac conduction abnormality
- Technically inadequate preoperative electrocardiogram
- Active preoperative electrolyte abnormality
- Acute coronary syndrome
- Heart failure
- Bilateral knee arthroplasty performed in the same session
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Spinal and General Anesthesia on Frontal QRS Axis in Patients Undergoing Total Knee Arthroplasty: A Prospective Observational Study
This prospective observational study aims to compare the effects of spinal and general anesthesia on frontal QRS axis in patients undergoing elective total knee arthroplasty. Adult patients aged 18 years and older with ASA physical status I to III will be included. Participants will be grouped according to the anesthesia technique applied in routine clinical practice. Standard 12-lead electrocardiography will be obtained preoperatively and postoperatively, and frontal QRS axis values will be recorded using the automatic measurements of the ECG device. The primary objective is to evaluate the preoperative-to-postoperative change in frontal QRS axis and to compare this change between patients receiving spinal anesthesia and those receiving general anesthesia. Demographic and perioperative variables, including comorbidities, intraoperative fluid administration, blood pressure, oxygen saturation, heart rate, and tourniquet time, will also be recorded. This study is designed to provide clinical information about the potential effects of anesthesia technique on cardiac electrical activity in patients undergoing total knee arthroplasty.
Read the detailed description
This is a single-center, prospective, observational, non-interventional clinical study to be conducted in the Department of Anesthesiology and Reanimation at Elazig Fethi Sekin City Hospital. The study population consists of adult patients scheduled for elective total knee arthroplasty under either spinal anesthesia or general anesthesia in routine clinical practice. Patients will not be assigned to an intervention by protocol; instead, they will be observed according to the anesthesia technique selected during standard care.
Eligible participants will be patients aged 18 years or older with ASA physical status I to III who undergo elective total knee arthroplasty under spinal or general anesthesia. Exclusion criteria include the presence of a pacemaker, known cardiac conduction abnormalities, technically inadequate preoperative electrocardiograms, active preoperative electrolyte abnormalities, acute coronary syndrome, heart failure, and bilateral knee arthroplasty performed in the same session.
For each participant, demographic and perioperative data will be collected, including age, sex, ASA class, comorbidities, intraoperative fluid volume, arterial blood pressure, oxygen saturation, heart rate, and tourniquet duration. Standard 12-lead electrocardiography will be recorded before surgery and again in the postoperative period before mobilization. Frontal QRS axis values will be obtained from the automatic measurements reported by the ECG device.
The primary outcome measure is the preoperative-to-postoperative change in frontal QRS axis. The main analysis will compare this change between the spinal anesthesia group and the general anesthesia group. Secondary analyses will examine perioperative and demographic factors that may be associated with changes in frontal QRS axis. According to the protocol, approximately 140 to 150 patients are planned for inclusion, taking into account possible loss to follow-up or incomplete data.
Statistical analyses will be performed using IBM SPSS Statistics version 25. Descriptive statistics will be presented as mean and standard deviation, median, or percentage, as appropriate. Between-group comparisons will be performed using the independent samples t test or Mann-Whitney U test depending on data distribution. Within-group preoperative and postoperative comparisons will be assessed using the paired samples t test or Wilcoxon signed-rank test. A p value below 0.05 will be considered statistically significant.
- Keywords
- spinal anesthesia, general anesthesia, frontal QRS axis, electrocardiography, total knee arthroplasty
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 |
|---|---|---|
| Spinal Anesthesia Cohort | Patients undergoing elective total knee arthroplasty under spinal anesthesia in routine clinical practice. Preoperative and postoperative frontal QRS axis values will be recorded and analyzed. | |
| General Anesthesia Cohort | Patients undergoing elective total knee arthroplasty under general anesthesia in routine clinical practice. Preoperative and postoperative frontal QRS axis values will be recorded and analyzed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frontal QRS axis
Preoperative-to-postoperative change in frontal QRS axis measured by standard 12-lead electrocardiography and compared between the spinal anesthesia cohort and the general anesthesia cohort.
Measured: From preoperative assessment to within 6 hours after surgery
Secondary outcomes (1)
Predictors of perioperative change in frontal QRS axis
Assessment of demographic and perioperative predictors of the preoperative-to-postoperative change in frontal QRS axis, measured in degrees by standard 12-lead electrocardiography. Candidate predictors will include age, sex, ASA physical status, comorbidities, anesthesia technique, intraoperative fluid volume, blood pressure, heart rate, oxygen saturation, and tourniquet time. The association between these variables and the preoperative-to-postoperative change in frontal QRS axis will be evaluated using multivariable regression analysis.
Measured: From preoperative assessment to within 6 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 posted27 Apr 2026
- Study start4 Sep 2025
- Primary completion3 Mar 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oğuz Kağan Bulut, md, Principal investigator, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551648
- Sponsor's protocol ID
- TDP-QRS-2025-01
- Acronym
- TDP-QRS
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no formal data-sharing plan has been established for this single-center observational study.
Publications
Duran HT, Cam BM, Tuzen AS, Akdogan MA, Evirgen S. The Effect of Obesity and General Anaesthesia Mode on the Frontal QRS-T Angle During Laparoscopic Surgery. Diagnostics (Basel). 2025 Aug 5;15(15):1962. doi: 10.3390/diagnostics15151962.
PubMed 40804926Kaya B, Arslan H, Polat N, et al. Frontal QRS-T angle: a novel and reliable ECG parameter reflecting ventricular repolarization heterogeneity. Cardiol J. 2025;32(7):845-853. doi:10.5603/CJ.a2025.012964
Tercan M, Uysal S, Çelik A, et al. Impact of body mass index on frontal QRS-T angle and repolarization changes in women undergoing cesarean section with spinal anesthesia. Anatol J Cardiol. 2024;28(2):95-103. doi:10.14744/AnatolJCardiol.2024.11356263
Kaya A, Yılmaz A, Demirtaş S, et al. Frontal QRS-T angle as a predictor of ventricular arrhythmogenesis and repolarization heterogeneity: clinical implications. Diagnostics (Basel). 2025;15(15):1962. doi:10.3390/diagnostics15151962.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Spinal and General Anesthesia on Frontal QRS Axis in Patients Undergoing Total Knee Arthroplasty: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07551648
- Acronym / sponsor ID
- TDP-QRS / TDP-QRS-2025-01
- Keywords
- spinal anesthesia, general anesthesia, frontal QRS axis, electrocardiography, total knee arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 27 Apr 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 compare the effects of spinal and general anesthesia on frontal QRS axis in patients undergoing elective total knee arthroplasty. Adult patients aged 18 years and older with ASA physical status I to III will be included. Participants will be grouped according to the anesthesia technique applied in routine clinical practice. Standard 12-lead electrocardiography will be obtained preoperatively and postoperatively, and frontal QRS axis values will be recorded using the automatic measurements of the ECG device. The primary objective is to evaluate the preoperative-to-postoperative change in frontal QRS axis and to compare this change between patients receiving spinal anesthesia and those receiving general anesthesia. Demographic and perioperative variables, including comorbidities, intraoperative fluid administration, blood pressure, oxygen saturation, heart rate, and tourniquet time, will also be recorded. This study is designed to provide clinical information about the potential effects of anesthesia technique on cardiac electrical activity in patients undergoing total knee arthroplasty.
Detailed description
This is a single-center, prospective, observational, non-interventional clinical study to be conducted in the Department of Anesthesiology and Reanimation at Elazig Fethi Sekin City Hospital. The study population consists of adult patients scheduled for elective total knee arthroplasty under either spinal anesthesia or general anesthesia in routine clinical practice. Patients will not be assigned to an intervention by protocol; instead, they will be observed according to the anesthesia technique selected during standard care.
Eligible participants will be patients aged 18 years or older with ASA physical status I to III who undergo elective total knee arthroplasty under spinal or general anesthesia. Exclusion criteria include the presence of a pacemaker, known cardiac conduction abnormalities, technically inadequate preoperative electrocardiograms, active preoperative electrolyte abnormalities, acute coronary syndrome, heart failure, and bilateral knee arthroplasty performed in the same session.
For each participant, demographic and perioperative data will be collected, including age, sex, ASA class, comorbidities, intraoperative fluid volume, arterial blood pressure, oxygen saturation, heart rate, and tourniquet duration. Standard 12-lead electrocardiography will be recorded before surgery and again in the postoperative period before mobilization. Frontal QRS axis values will be obtained from the automatic measurements reported by the ECG device.
The primary outcome measure is the preoperative-to-postoperative change in frontal QRS axis. The main analysis will compare this change between the spinal anesthesia group and the general anesthesia group. Secondary analyses will examine perioperative and demographic factors that may be associated with changes in frontal QRS axis. According to the protocol, approximately 140 to 150 patients are planned for inclusion, taking into account possible loss to follow-up or incomplete data.
Statistical analyses will be performed using IBM SPSS Statistics version 25. Descriptive statistics will be presented as mean and standard deviation, median, or percentage, as appropriate. Between-group comparisons will be performed using the independent samples t test or Mann-Whitney U test depending on data distribution. Within-group preoperative and postoperative comparisons will be assessed using the paired samples t test or Wilcoxon signed-rank test. A p value below 0.05 will be considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia Cohort | – | –Patients undergoing elective total knee arthroplasty under spinal anesthesia in routine clinical practice. Preoperative and postoperative frontal QRS axis values will be recorded and analyzed. |
| General Anesthesia Cohort | – | –Patients undergoing elective total knee arthroplasty under general anesthesia in routine clinical practice. Preoperative and postoperative frontal QRS axis values will be recorded and analyzed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective total knee arthroplasty at a single center and managed with either spinal anesthesia or general anesthesia in routine clinical practice.
Key inclusion criteria (4 listed)
- Adults aged 18 years and older
- Patients scheduled for elective total knee arthroplasty
- ASA physical status I to III
- Patients undergoing surgery under spinal anesthesia or general anesthesia
Key exclusion criteria (7 listed)
- Presence of a pacemaker
- Known cardiac conduction abnormality
- Technically inadequate preoperative electrocardiogram
- Active preoperative electrolyte abnormality
- Acute coronary syndrome
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
Time frame: From preoperative assessment to within 6 hours after surgery
Preoperative-to-postoperative change in frontal QRS axis measured by standard 12-lead electrocardiography and compared between the spinal anesthesia cohort and the general anesthesia cohort.
1 secondary outcome
Predictors of perioperative change in frontal QRS axis
Time frame: From preoperative assessment to within 6 hours after surgery
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 4 Jun 2026.
- Background: PubMed 40804926Duran HT, Cam BM, Tuzen AS, Akdogan MA, Evirgen S. The Effect of Obesity and General Anaesthesia Mode on the Frontal QRS-T Angle During Laparoscopic Surgery. Diagnostics (Basel). 2025 Aug 5;15(15):1962. doi: 10.3390/diagnostics15151962.
- BackgroundKaya B, Arslan H, Polat N, et al. Frontal QRS-T angle: a novel and reliable ECG parameter reflecting ventricular repolarization heterogeneity. Cardiol J. 2025;32(7):845-853. doi:10.5603/CJ.a2025.012964
- BackgroundTercan M, Uysal S, Çelik A, et al. Impact of body mass index on frontal QRS-T angle and repolarization changes in women undergoing cesarean section with spinal anesthesia. Anatol J Cardiol. 2024;28(2):95-103. doi:10.14744/AnatolJCardiol.2024.11356263
- BackgroundKaya A, Yılmaz A, Demirtaş S, et al. Frontal QRS-T angle as a predictor of ventricular arrhythmogenesis and repolarization heterogeneity: clinical implications. Diagnostics (Basel). 2025;15(15):1962. doi:10.3390/diagnostics15151962.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no formal data-sharing plan has been established for this single-center observational study.
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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.
Oğuz Kağan Bulut, md principal investigator
Elazıg Fethi Sekin Sehir Hastanesi
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 Total Knee Arthroplasty and Electrocardiographic Changes, run by Elazıg Fethi Sekin Sehir Hastanesi 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 7 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 4 Jun 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?
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 (time frame: From preoperative assessment to within 6 hours after surgery). 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 NCT07551648, which also lists 4 linked publications.
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 4 Jun 2026.