Viewing Study NCT06651450



Ignite Creation Date: 2024-10-26 @ 3:43 PM
Last Modification Date: 2024-10-26 @ 3:43 PM
Study NCT ID: NCT06651450
Status: ENROLLING_BY_INVITATION
Last Update Posted: None
First Post: 2024-10-16

Brief Title: Electrocardiographic Changes in Cholecystectomy Surgery
Sponsor: None
Organization: None

Study Overview

Official Title: Investigation of Perioperative Electrocardiographic Changes in Laparoscopic Cholecystectomy Surgery
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 patientsTherefore researchers aimed to investigate the effects of increased IAP on electrocardiography in patients undergoing laparoscopic cholecystectomy
Detailed Description: 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 QTQTc 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 QTQTc 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None