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临床试验/NCT07551648
NCT07551648已完成不适用

Comparison of the Effects of Spinal and General Anesthesia on Frontal QRS Axis in Patients Undergoing Total Knee Arthroplasty: A Prospective Observational Study

Elazıg Fethi Sekin Sehir Hastanesi1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
Change in frontal QRS axis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

结局指标

主要结局

Change in frontal QRS axis

时间窗: 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.

次要结局

  • Association of perioperative variables with change in frontal QRS axis(From preoperative assessment to within 6 hours after surgery)

研究者

发起方
Elazıg Fethi Sekin Sehir Hastanesi
申办方类型
Other
责任方
Sponsor

研究点 (1)

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