Skip to main content
OpenTrials
Completed

NCT Number: NCT07834060

Perioperative QT and QTc Changes in Laparoscopic and Open Hysterectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Sultangazi Haseki Training and Research Hospital

Istanbul, 34265, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Anemia
  • Neuromuscular disease
  • Refusal to participate

Treatment and study plan

laparoscopic hysterectomy

Procedure

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.

Open Abdominal Hysterectomy

Procedure

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.

Primary outcomes

  1. Perioperative Change in QT Interval

    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.

  2. Perioperative Change in Corrected QT (QTc) Interval

    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.

Secondary outcomes

  1. Maximum Perioperative Change in QT Interval (ΔQT)

    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.

  2. Maximum Perioperative Change in QTc Interval (ΔQTc)

    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.

  3. Incidence of Hypotension

    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.

  4. Incidence of bradycardia

    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.

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

Comparison of Perioperative QT and QTc Changes Between Laparoscopic and Open Abdominal Hysterectomy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

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.