QT IntervalNCT07834060
Perioperative QT and QTc Changes in Laparoscopic and Open Hysterectomy
An observational study of QT Interval and Hysterectomy, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- QT Interval, Hysterectomy
- What is being tested?
- Laparoscopic hysterectomy and Open Abdominal Hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2023to 15 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- Permanent pacemaker
- Electrolyte abnormalities
- Chronic obstructive pulmonary disease
- Hepatic disease
- Renal disease
- Anemia
- Neuromuscular disease
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultangazi Haseki Training and Research Hospital
Istanbul, Istanbul, 34265
About this study
Official title: Comparison of Perioperative QT and QTc Changes Between Laparoscopic and Open Abdominal 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.
Read the detailed description
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.
- Conditions
- QT Interval, Hysterectomy
- Being tested
- Laparoscopic hysterectomy, Open Abdominal Hysterectomy
- Keywords
- QT interval, QTc interval, cardiac repolarization, laparoscopic hysterectomy, abdominal hysterectomy, pneumoperitoneum, general anesthesia, electrocardiography
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic hysterectomyProcedure or surgery
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 HysterectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Laparoscopic hysterectomy | |
| 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. Receives: Procedure: Open Abdominal Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From before induction of general anesthesia to immediately after tracheal extubation on the day of surgery.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From before induction of anesthesia to immediately after extubation on the day of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start15 Oct 2023
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for QT IntervalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinan Uzman, Haseki Training and Research Hospital
- Investigators
- Sinan Uzman, Assoc. prof., Study director, Sultangazi Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834060
- Sponsor's protocol ID
- 171-2023
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Stamate E, Piraianu AI, Duca OM, Ciobotaru OR, Fulga A, Fulga I, Onisor C, Matei MN, Luchian AS, Dumitrascu AG, Ciobotaru OC. The Effect of Increased Intra-Abdominal Pressure on Hemodynamics in Laparoscopic Cholecystectomy-The Experience of a Single Centre. J Pers Med. 2024 Aug 17;14(8):871. doi: 10.3390/jpm14080871.
PubMed 39202062
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perioperative QT and QTc Changes Between Laparoscopic and Open Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT07834060
- Acronym / sponsor ID
- 171-2023
- Conditions
- QT Interval, Hysterectomy
- Keywords
- QT interval, QTc interval, cardiac repolarization, laparoscopic hysterectomy, abdominal hysterectomy, pneumoperitoneum, general anesthesia, electrocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L - laparoscopic hysterectomy | – | Procedure: Laparoscopic hysterectomyAdult 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. |
| Group A - abdominal abdominal hysterectomy | – | Procedure: Open Abdominal HysterectomyAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic hysterectomyAdult 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 or surgery | Group L - laparoscopic hysterectomy |
| Open Abdominal HysterectomyAdult 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 or surgery | Group A - abdominal abdominal hysterectomy |
Primary outcome
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.
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.
4 secondary outcomes
Maximum Perioperative Change in QT Interval (ΔQT)
Time frame: From before induction of anesthesia to immediately after extubation on the day of surgery.
Maximum Perioperative Change in QTc Interval (ΔQTc)
Time frame: From before induction of anesthesia to immediately after extubation on the day of surgery.
Incidence of Hypotension
Time frame: From before induction of anesthesia to immediately after extubation on the day of surgery.
Incidence of bradycardia
Time frame: From before induction of anesthesia to immediately after extubation on the day of surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 39202062Stamate E, Piraianu AI, Duca OM, Ciobotaru OR, Fulga A, Fulga I, Onisor C, Matei MN, Luchian AS, Dumitrascu AG, Ciobotaru OC. The Effect of Increased Intra-Abdominal Pressure on Hemodynamics in Laparoscopic Cholecystectomy-The Experience of a Single Centre. J Pers Med. 2024 Aug 17;14(8):871. doi: 10.3390/jpm14080871.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sinan Uzman, Assoc. prof. study director
Sultangazi Haseki Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of QT Interval and Hysterectomy, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Change in QT Interval (time frame: From before induction of general anesthesia to immediately after tracheal extubation on the day of surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07834060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.