Comparison of Perioperative QT and QTc Changes Between Laparoscopic and Open Abdominal Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Perioperative Change in QT Interval
研究概览
简要总结
This prospective observational study evaluated perioperative changes in QT and corrected QT (QTc) intervals in adult women undergoing elective laparoscopic or open abdominal hysterectomy under general anesthesia. The surgical approach was determined by the treating gynecologic surgeon according to routine clinical considerations and was not assigned by the investigators. All patients received a standardized general anesthesia and monitoring protocol. QT and QTc intervals were recorded at predefined perioperative time points from before anesthesia induction to immediately after tracheal extubation. The study aimed to compare the magnitude and pattern of perioperative QT and QTc changes between laparoscopic and open abdominal hysterectomy and to evaluate associated perioperative hemodynamic and respiratory adverse events.
详细描述
This was a prospective, single-center observational cohort study including 48 adult female patients with American Society of Anesthesiologists physical status I-II undergoing elective hysterectomy under general anesthesia. Patients were classified into two cohorts according to the surgical approach: laparoscopic hysterectomy (Group L) and open abdominal hysterectomy (Group A). The surgical technique was selected independently by the treating gynecologic surgeon based on clinical considerations and was not determined by the study investigators.
A standardized general anesthesia protocol was applied to both groups. Continuous electrocardiographic monitoring was performed, and QT intervals were automatically measured from lead II using the perioperative monitoring system. Corrected QT intervals were calculated automatically using Bazett's formula.
QT and QTc intervals were evaluated at predefined perioperative time points: before anesthesia induction (T0), after anesthesia induction (T1), immediately before tracheal intubation (T2), immediately after tracheal intubation (T3), before the relevant surgical stimulus (T4), immediately after the surgical stimulus (T5), at the end of surgery (T6), and immediately after tracheal extubation (T7). In addition, the difference between the maximum and minimum perioperative QT and QTc values obtained from measurements recorded at five-minute intervals was evaluated. Hemodynamic and respiratory adverse events were also recorded.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patients scheduled for elective laparoscopic or open abdominal hysterectomy under general anesthesia
- •American Society of Anesthesiologists physical status I-II
- •Written informed consent for participation
排除标准
- •Unstable angina
- •Severe heart failure
- •Preoperative QTc interval >460 ms
- •Use of medications known to affect the QTc interval
- •Family history of long QT syndrome
- •Cardiac arrhythmia or conduction abnormality on electrocardiography
- •Permanent pacemaker
- •Electrolyte abnormalities
- •Chronic obstructive pulmonary disease
- •Hepatic disease
- •Renal disease
- •Neuromuscular disease
- •Refusal to participate
研究组 & 干预措施
Group L - laparoscopic hysterectomy
Adult female patients undergoing elective laparoscopic hysterectomy under general anesthesia. The laparoscopic surgical approach was selected by the treating gynecologic surgeon as part of routine clinical care and was not assigned by the investigators.
干预措施: Laparoscopic hysterectomy (Procedure)
Group A - abdominal abdominal hysterectomy
Adult female patients undergoing elective open abdominal hysterectomy under general anesthesia. The open surgical approach was selected by the treating gynecologic surgeon as part of routine clinical care and was not assigned by the investigators.
干预措施: Open Abdominal Hysterectomy (Procedure)
结局指标
主要结局
Perioperative Change in QT Interval
时间窗: From before induction of general anesthesia to immediately after tracheal extubation on the day of surgery.
QT interval, expressed in milliseconds (ms), was automatically measured from lead II of the electrocardiogram. QT intervals were assessed at eight predefined perioperative time points (T0-T7) and compared according to time, surgical group, and group × time interaction.
Perioperative Change in Corrected QT (QTc) Interval
时间窗: From before induction of general anesthesia to immediately after tracheal extubation on the day of surgery.
Corrected QT (QTc) interval, expressed in milliseconds (ms), was automatically calculated using Bazett's formula (QTc = QT/√RR). QTc intervals were assessed at eight predefined perioperative time points (T0-T7) and compared according to time, surgical group, and group × time interaction.
次要结局
- Incidence of bradycardia(From before induction of anesthesia to immediately after extubation on the day of surgery.)
- Maximum Perioperative Change in QT Interval (ΔQT)(From before induction of anesthesia to immediately after extubation on the day of surgery.)
- Maximum Perioperative Change in QTc Interval (ΔQTc)(From before induction of anesthesia to immediately after extubation on the day of surgery.)
- Incidence of Hypotension(From before induction of anesthesia to immediately after extubation on the day of surgery.)
研究者
Sinan Uzman
Associate prof.
Haseki Training and Research Hospital