An observational study in QT Interval and Hysterectomy, sponsored by Haseki Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Haseki Training and Research Hospital · Observational
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.
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.
134 studies on the registry are indexed under Pneumoperitoneum; 28 are open to participants now.
This study's enrollment of 48 is below the median of 59 across 48 observational studies indexed under Pneumoperitoneum.
Browse Pneumoperitoneum studies →Haseki Training and Research Hospital is the lead sponsor of 78 studies on the registry; 17 are open to participants now.
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Adult female patients with ASA physical status I-II undergoing elective laparoscopic or open abdominal hysterectomy under general anesthesia at Sultangazi Haseki Training and Research Hospital, Istanbul, Türkiye.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Laparoscopic 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.
Procedure: Open Abdominal 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.
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.
Perioperative Change in QT Interval
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.
Perioperative Change in Corrected QT (QTc) Interval
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 general anesthesia to immediately after tracheal extubation on the day of surgery.
Maximum Perioperative Change in QT Interval (ΔQT)
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.
Maximum Perioperative Change in QTc Interval (ΔQTc)
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.
Incidence of Hypotension
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.
Incidence of bradycardia
Number and percentage of participants who developed intraoperative bradycardia, defined as heart rate \<60 bpm.
Time frame: From before induction of anesthesia to immediately after extubation on the day of surgery.
Plan to share: No — Individual participant data will not be shared because data sharing was not included in the study's approved protocol and participant consent, and no data-sharing arrangements have been established.
Ran from Oct 2023 to primary completion in Jan 2024, 3 months.
Of 26 observational studies under Pneumoperitoneum, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Haseki Training and Research Hospital