Elazığ Fethi Sekin City Hospital
Elâzığ, Merkez, 23200, Turkey (Türkiye)
NCT Number: NCT07112313
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.
Looking for future studies?
Notify Me45 year–85 year
All sexes
Observational
Elâzığ, Merkez, 23200, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Sevim Şenol Karataş
Other
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
Acronym: FQRS-TKA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04485650
Anxiety, Anxiety Disorders
Bolu, Turkey (Türkiye)
View Trial DetailsNCT00537472
Spinal Anesthesia, Total Knee Arthroplasty
Kingston, Ontario, Canada
View Trial DetailsNCT07718360
Cesarean Section Pain, Neurologic Manifestations
Islamabad, Federal Capital Territory, Pakistan
View Trial DetailsNCT06711601
Intercristal Line, Posterior Superior Iliac Spine
Guangzhou, Guangdong, China
View Trial Details