Sultangazi Haseki Training and Research Hospital
Istanbul, 34265, Turkey (Türkiye)
NCT Number: NCT07834060
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.
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Female
Observational
Istanbul, 34265, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: From before induction of anesthesia to immediately after extubation on the day of surgery.
Difference, expressed in milliseconds, between the maximum and minimum QT intervals recorded during perioperative measurements obtained at five-minute intervals.
Time frame: From before induction of anesthesia to immediately after extubation on the day of surgery.
Difference, expressed in milliseconds, between the maximum and minimum QTc intervals recorded during perioperative measurements obtained at five-minute intervals.
Time frame: From before induction of anesthesia to immediately after extubation on the day of surgery.
Number and percentage of participants who developed intraoperative hypotension, defined as mean arterial pressure ≤70 mmHg.
Time frame: From before induction of anesthesia to immediately after extubation on the day of surgery.
Number and percentage of participants who developed intraoperative bradycardia, defined as heart rate <60 bpm.
Haseki Training and Research Hospital
Other
Comparison of Perioperative QT and QTc Changes Between Laparoscopic and Open Abdominal Hysterectomy
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