NCT07551648

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 20, 2026

Last Update Submit

April 20, 2026

Conditions

Keywords

spinal anesthesiageneral anesthesiafrontal QRS axiselectrocardiographytotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • 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.

    From preoperative assessment to within 6 hours after surgery

Secondary Outcomes (1)

  • Association of perioperative variables with change in frontal QRS axis

    From preoperative assessment to within 6 hours after surgery

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, Turkey (Türkiye)

Location

Related Publications (4)

  • Duran Ö, Çetin E, Korkmaz A, et al. Effects of obesity on intraoperative frontal QRS-T angle and QT interval in laparoscopic surgery patients. Diagnostics (Basel). 2025;15(15):1962. doi:10.3390/diagnostics15151962.

    BACKGROUND
  • Kaya 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND

Study Officials

  • Oğuz Kağan Bulut, md

    Elazıg Fethi Sekin Sehir Hastanesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 27, 2026

Study Start

September 4, 2025

Primary Completion

March 3, 2026

Study Completion

March 10, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because no formal data-sharing plan has been established for this single-center observational study.

Locations