Effect of Intraoperative Position Change on Hemodynamics and Cardiac Electrophysiological Balance Index in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluation of the QT (ms) interval in morbidly obese patients undergoing laparoscopic sleeve gastrectomy.
研究概览
简要总结
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.
详细描述
Morbidly obese patients who will undergo laparoscopic sleeve gastrectomy will be included in the study.
Patients will be taken to the operating room without premedication after a minimum of 8 hours of fasting. Venous access will be established with a 22 G angiocatheter on the operating table. Routine heart rate, arterial blood pressure, peripheral oxygen saturation (SpO₂), body temperature, bispectral index (BIS) (Bispectral Drager Vista 120 system, Covidien, USA) monitoring will be performed. BIS will be kept between 40 - 60. In addition, 12-lead ECG (Cardioline®) will be used for electrocardiogram (ECG) measurements.
Mechanical ventilation will be provided with a tidal volume of 8 mL/kg (IBW) and a positive end expiratory pressure (PEEP) of 8 cmH₂O. The respiratory rate will be adjusted to maintain end-tidal carbon dioxide (EtCO2) at 35 to 45 mmHg.
Targeted Fluid Management (GDFM) will be provided by continuous Pleth Variability Index (PVI) monitoring by placing a Pulse CO-Oximeter sensor system (Masimo rainbow set® Masimo Corporation, Irvine, CA, USA) on the patients' 4th finger. Hemodynamic targets are both PVI and mean arterial pressure. Fluid loading prescription is based on a PVI value greater than 13%, and vasopressor use is based on a mean arterial pressure < 65 mmHg. If necessary, additional fluids and norepinephrine will be given to maintain mean arterial pressure > 65 mmHg.
A 12-lead ECG will be taken at five intraoperative position measurement points (1. Supine-monitored; 2. After induction; 3. Under general anesthesia-Supine-abdominal inflated; 4. Abdominal inflated-(30% upright) Reverse Trendelenburg; 5. Abdominal deflated-(30% upright) Reverse Trendelenburg). Hemodynamic monitoring [systolic blood pressure (SBP), diastolic blood pressure (DAB), mean arterial pressure (MAP), heart rate (HR)] will be recorded at 5 simultaneous measurement points. All hemodynamic measurements and ECG recordings will be made 3 minutes after the position change to ensure standardization, allow the response to settle after the position change, and prevent the possibility of exaggerated or false data.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient planned for elective primary laparoscopic sleeve gastrectomy surgery
- •Body Mass Index (BMI) ≥ 40 kg/ / m²
- •ASA physical health class II-III.
排除标准
- •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
结局指标
主要结局
Evaluation of the QT (ms) interval in morbidly obese patients undergoing laparoscopic sleeve gastrectomy.
时间窗: The operation takes approximately 2 hours to complete.
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)
Evaluation of QRS (ms) interval in morbidly obese patients undergoing laparoscopic sleeve gastrectomy.
时间窗: The operation takes approximately 2 hours to complete.
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)
Evaluation of the cardiac electrophysiological balance index (QT/QRS) in morbidly obese patients undergoing laparoscopic sleeve gastrectomy.
时间窗: The operation takes approximately 2 hours to complete.
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.
Patient height measurement (in meters)
时间窗: Height measurement for each patient takes approximately 10 minutes.
All patients' heights will be measured (in meters).
Patients' body weight measurement (kilograms)
时间窗: Body weight measurement takes approximately 10 minutes for each patient.
Patients' body weights will also be measured (in kilograms).
Calculation of body mass index (BMI = kg/m²).
时间窗: This will take approximately 10 minutes for each patient.
Body Mass Index (BMI) is calculated by dividing body weight (kg) by the square of height (m) (BMI = kg/m²).
次要结局
- 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.)
研究者
Fatma Çelik
Assoc. Prof. Dr.
Firat University