Effect of Intraoperative Position Change on Hemodynamics and Electrocardiography

NCT06835166 | Completed DMC

• 1 other identifier: FiratU-ANEST-FC-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The combined effects of obesity-related cardiac structure and function changes, comorbidities, pneumoperitoneum technique, and reverse Trendelenburg position may complicate anesthesia management by affecting intraoperative hemodynamics and cardiac function. Increased intra-abdominal pressure leads to various physiological changes through mechanical and neurohormonal responses. Furthermore, pneumoperitoneum and reverse Trendelenburg position are reported to stimulate the sympathetic nervous system and increase the risk of cardiac arrhythmia. Obesity-related changes in cardiac structure and function have been shown to predispose to cardiac conduction and repolarization disorders. It has also been stated that obesity directly affects cardiac electrophysiology. Moreover, obese patients may have hidden risks associated with the development of cardiac arrhythmias due to the adverse contributions of the cardiovascular effects of anesthesia, pneumoperitoneum, and patient positioning during laparoscopic intervention. The index of cardiac electrophysiological balance (iCEB) is a non-invasive marker calculated by the QT/QRS ratio that can predict malignant ventricular arrhythmias. The aim of this study was to investigate the effects of intraoperative patient positions on hemodynamics and the index of cardiac electrophysiological balance (iCEB) during laparoscopic sleeve gastrectomy in morbidly obese patients.

Conditions

Bariatric Surgery (Sleeve Gastrectomy ); Hemodynamics; Electrocardiography

Keywords

Bariatric Surgery; Laparoscopic sleeve gastrectomy

Outcome Measures

Primary Outcomes (6)

• Evaluation of the QT (ms) interval in morbidly obese patients undergoing laparoscopic sleeve gastrectomy.

  Electrocardiograms will be recorded in the following predefined positions: 1\. Supine - monitored; 2. Post-anesthesia; 3. Under general anesthesia - Supine - abdominal distension; 4. Abdominal distension - (30% vertical) Reverse Trendelenburg; 5. Abdominal distension reduced - (30% vertical) Reverse Trendelenburg)

  The operation takes approximately 2 hours to complete.

• Evaluation of QRS (ms) interval in morbidly obese patients undergoing laparoscopic sleeve gastrectomy.

  Electrocardiograms will be recorded in the following predefined positions: (1. Supine - monitored; 2. Post-anesthesia; 3. Under general anesthesia - Supine - abdominal distension; 4. Abdominal distension - (30% vertical) Reverse Trendelenburg; 5. Abdominal distension reduced - (30% vertical) Reverse Trendelenburg)

  The operation takes approximately 2 hours to complete.

• Evaluation of the cardiac electrophysiological balance index (QT/QRS) in morbidly obese patients undergoing laparoscopic sleeve gastrectomy.

  The QT interval will be measured from the beginning of the QRS complex to the end of the T wave, and the QT/QRS (iCEB) ratio will be calculated.

  The operation takes approximately 2 hours to complete.

• Patient height measurement (in meters)

  All patients' heights will be measured (in meters).

  Height measurement for each patient takes approximately 10 minutes.

• Patients' body weight measurement (kilograms)

  Patients' body weights will also be measured (in kilograms).

  Body weight measurement takes approximately 10 minutes for each patient.

• Calculation of body mass index (BMI = kg/m²).

  Body Mass Index (BMI) is calculated by dividing body weight (kg) by the square of height (m) (BMI = kg/m²).

  This will take approximately 10 minutes for each patient.

Secondary Outcomes (2)

• Evaluation of patients' blood pressure measurements (mmHg)

  The operation takes approximately 2 hours to complete.

• measurement of patients' heart rates (beats/min)

  The operation takes approximately 2 hours to complete.

Interventions

12-lead electrocardiography measurement PROCEDURE

Intraoperative 12-lead electrocardiography (EKG) measurement during laparoscopic sleeve gastrectomy in morbidly obese patients: In all patients, pneumoperitoneum CO₂ intraabdominal pressure will be studied as 15 cmH₂O. Intraoperatively, 12-lead ECG will be obtained at five position measurement points: Procedure1. Supine-monitored; Procedure 2. After induction; Procedure 3. Under general anesthesia-Supine-abdominal inflated; Procedure 4. Abdominal inflated-(30% vertical) Reverse Trendelenburg; Procedure 5. Abdominal deflated-(30% vertical) Reverse Trendelenburg. Hemodynamic monitoring \[systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate \] was recorded at 5 simultaneous measurement points. All hemodynamic measurements and ECG recordings will be performed 3 minutes after the position change to ensure standardization, to allow the response to settle after the position change, and to prevent the possibility of exaggerated-incorrect data.

Eligibility Criteria

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

Study Population

Morbidly obese patients undergoing laparoscopic sleeve gastrectomy

You may qualify if:

• Adult patient planned for elective primary laparoscopic sleeve gastrectomy surgery
• Body Mass Index (BMI) ≥ 40 kg/ / m²
• Age ≥ 18
• ASA physical health class II-III.

You may not qualify if:

• Patient refusal to participate in the study
• Those who underwent revision laparoscopic sleeve gastrectomy
• Emergency laparoscopic sleeve gastrectomy surgery (stump leakage, etc.)
• Secondary surgery in addition to elective laparoscopic sleeve gastrectomy
• Patients with previous recurrent abdominal surgery
• Patients with electrolyte imbalance
• Direct laryngoscopy in ramp position
• Multiple intubation attempts due to difficult intubation
• Preoperative arrhythmia and heart failure (ejection fraction \< 30%)
• Renal and liver failure
• Patients who require \> 8 ml/kg for tidal volume

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Firat University Hospital, Department of Anesthesiology and Reanimation

Elâzığ, 23200, Turkey (Türkiye)

Location

Related Publications (1)

• Atkinson TM, Giraud GD, Togioka BM, Jones DB, Cigarroa JE. Cardiovascular and Ventilatory Consequences of Laparoscopic Surgery. Circulation. 2017 Feb 14;135(7):700-710. doi: 10.1161/CIRCULATIONAHA.116.023262.

  PMID: 28193800 BACKGROUND

Related Links

• Echocardiographic and hemodynamic evaluation of cardiovascular performance during laparoscopy of morbidly obese patients
• Evaluation of index of cardio-electrophysiological balance in patients with coronary slow flow

Study Officials

• Fatma Çelik, Assoc. Dr.

  fatma.celik@firat.edu.tr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 19, 2025
• Study Start: February 10, 2025
• Primary Completion: April 25, 2025
• Study Completion: May 20, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

TU (1)