Electrocardiographic Changes in Cholecystectomy Surgery

NCT06651450 | Completed

• 1 other identifier: 24-KAEK-215
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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 patients.Therefore, researchers aimed to investigate the effects of increased IAP on electrocardiography in patients undergoing laparoscopic cholecystectomy.

Conditions

Laparoscopic Cholecystectomy; Vector Electrocardiography

Keywords

Electrocardiography; general anesthesia; pneumoperitoneum; vectorcardiography; cardiac arrhythmias

Outcome Measures

Primary Outcomes (1)

• frontal plane QRS-T angle, QT and QTc interval

  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.

  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.

Study Arms (1)

Patients who underwent laparoscopic cholecystectomy surgery

Effects of increasing IAB on frontal plane QRS-T angle, QT and QTc in ECG at different stages of surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People between the ages of 18-65 who are scheduled to undergo laparoscopic cholecystectomy are included in the study. When calculating the sample size; when the effect size obtained from the previous study was accepted as 0.4, the type 1 error value as 0.05, and the power as 0.80, it was determined that the sample size for the study was sufficient with 44 patients. Considering the losses that may occur during follow-up, it was planned to conduct the study with 48 patients with a 10% increase.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, Center, 600100, Turkey (Türkiye)

Location

Related Publications (1)

• Genc A, Ozsoy U, Sahin AT, Gurler Balta M, Kolukcu V, Genc Tapar G, Karaman T, Karaman S. Intra-abdominal hypertension and reverse Trendelenburg position increase frontal QRS-T angle in laparoscopic cholecystectomy: An observational study. Medicine (Baltimore). 2025 Mar 14;104(11):e41934. doi: 10.1097/MD.0000000000041934.

  PMID: 40101078 DERIVED

MeSH Terms

Conditions

Pneumoperitoneum; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 21, 2024
• Study Start: September 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 10, 2026

Record last verified: 2025-08

Locations

TU (1)