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Completed

NCT Number: NCT06651450

Electrocardiographic Changes in Cholecystectomy Surgery

Laparoscopic (closed) surgery provides several advantages over open surgery, such as smaller surgical incisions, postoperative recovery, and shorter hospital stay. However, increased intra-abdominal pressure (IAP) during surgery may have adverse effects on some systems such as circulation and respiration. Increased IAP may reduce blood return to the heart. Some studies have shown that some values calculated from surface electrocardiography are associated with changes in heart rhythm. Changes in blood pressure, nervous, and hormonal systems that may be seen due to increased IAP in laparoscopic surgery may cause arrhythmias in patients.Therefore, researchers aimed to investigate the effects of increased IAP on electrocardiography in patients undergoing laparoscopic cholecystectomy.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokat Gaziosmanpasa University

Tokat Province, Center, 600100, Turkey (Türkiye)

About this study

Laparoscopic cholecystectomy has been shown to have advantages such as less postoperative pain, early onset of bowel movements, shortening of hospital stay, early return to daily activities and better aesthetic results compared to open surgery. However, increased intra-abdominal pressure (IAP) can negatively affect the respiratory, circulatory, neuroendocrine and central nervous systems. Increased IAP can compress the vena cava and abdominal aorta, causing deterioration in the perfusion of other organs, especially the kidneys and spleen. In addition, this pathological process reduces the preload of the heart, stroke volume, cardiac output and increases central venous pressure, pulmonary capillary wedge pressure, pulmonary artery pressure and left ventricular afterload. IAP can also affect the pressure in the coronary arteries and impair the nutrition of the heart. It should be noted that increased IAP has also been identified as an independent risk factor for mortality in critically ill patients. The QT interval, which represents the time required for ventricular depolarization and repolarization on the ECG, is the time interval from the beginning of the QRS complex to the end of the T wave. Since the Qt interval is affected by the heart rate, it is called QT corrected according to the heart rate, QTc. Prolongation of the peroperative QT and QTc intervals can result in serious complications such as serious arrhythmias, ventricular tachycardia, ventricular fibrillation, and cardiac arrest. Variable QT intervals have been associated with heterogeneous repolarization and ventricular arrhythmias. The frontal plane QRS-T angle is expressed as the absolute difference between the QRS and T wave axes. The frontal plane QRS-T angle, a parameter that can be easily calculated from the 12-lead surface ECG, is considered a marker of ventricular repolarization heterogeneity. Increased ventricular repolarization heterogeneity is associated with an increased risk of arrhythmogenesis. Studies have shown that increased frontal plane QRS-T angle leads to an increased risk of cardiovascular and arrhythmic events and is associated with an increased risk of mortality. Previous publications have reported that the frontal plane QRS-T angle value is stronger, more renewable, and less affected by external factors than the QT/QTc value in showing ventricular repolarization. A wider frontal plane QRS-T angle is considered a strong and independent risk indicator for cardiac morbidity and mortality compared to other traditional cardiovascular risk factors such as the length of the QT interval and electrocardiographic risk indicators. The increase in IAP in laparoscopic surgeries, anesthetic drugs, patient positions, and neuroendocrine response may increase the risk of arrhythmia in the patient. There are many studies on the effects of laparoscopic surgeries, anesthetic drugs, and anesthesia methods that increase IAP on the QT/QTc duration, and there are a limited number of studies in the literature on the effects of another repolarization parameter, the frontal plane QRS-T angle. In this study, researchers investigated perioperative frontal QRS-T angle change and risk of arrhythmia predisposition in patients undergoing laparoscopic cholecystectomy under general anesthesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 18-65 who wish to participate in the study and undergo laparoscopic cholecystectomy

Exclusion criteria

  • Cardiovascular diseases (coronary artery disease, atrial fibrillation, atrial flutter, heart failure, pacemaker, ICD, CRT, bundle branch block)
  • Serious respiratory diseases
  • Electrolyte disorders
  • Renal failure
  • Metabolic diseases
  • Advanced psychiatric diseases

Treatment and study plan

Primary outcomes

  1. frontal plane QRS-T angle, QT and QTc interval

    Time frame: EECG recordings will be taken immediately before surgery, before and immediately after intra-abdominal CO2 insufflation, 2 minutes after reverse Trendelenburg, immediately after the patient is awakened, and at the 2nd hour after surgery.

    The frontal plane QRS-T angle, which is accepted as the ventricular repolarization parameter, describes the angle between the QRS and T axes calculated from the surface ECG.The QT interval, which represents the time required for ventricular depolarization and repolarization on the ECG, is the time interval from the beginning of the QRS complex to the end of the T wave.

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

Investigation of Perioperative Electrocardiographic Changes in Laparoscopic Cholecystectomy Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 21, 2024
Registry last updated
Mar 10, 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.

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