Frontal QRS Axis Changes in Patients Undergoing Total Knee Arthroplasty With Spinal Anesthesia (FQRS-TKA)

NCT07112313 | Completed

• 1 other identifier: EFSH-ANES-2025-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spinal Anesthesia; Total Knee Arthroplasty

Keywords

Frontal QRS axis; Spinal anesthesia; Total knee replacement; Electrocardiogram (ECG); Postoperative ECG changes; Regional anesthesia; Orthopedic surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  From 2 hours before to 2 hours after surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 45-85 years undergoing elective total knee arthroplasty under spinal anesthesia at Elazığ Fethi Sekin City Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sevim Şenol Karataş: lead

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, Merkez, 23200, Turkey (Türkiye)

Location

Study Officials

• Sevim Ş Karataş, MD

  Elazığ Fethi Sekin City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist in Anesthesiology

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: September 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)