Effect of Intraoperative Salbutamol Administration on Mechanical Power and Respiratory Mechanics in Obese Patients Undergoing Laparoscopic Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in intraoperative mechanical power
研究概览
简要总结
The primary objective of this study is to evaluate the effect of intraoperative salbutamol administration on mechanical power in obese patients undergoing laparoscopic bariatric surgery under general anesthesia. Mechanical power will be measured at predefined intraoperative time points (T0, T1, and T2), and changes over time will be compared to determine the impact of salbutamol on the overall energy delivered to the respiratory system during mechanical ventilation.
Secondary objectives include the assessment of intraoperative respiratory mechanics, including peak airway pressure (Ppeak), plateau pressure (Pplat), driving pressure (Pdrive), airway resistance (Raw), and lung compliance, as well as gas exchange parameters (SpO₂, EtCO₂) and hemodynamic variables (mean arterial pressure). Postoperative pulmonary outcomes will be evaluated using the Melbourne Group Scale (MGS), with a score greater than 4 indicating the presence of postoperative pulmonary complications. The study aims to investigate whether improvement in intraoperative mechanical power and respiratory mechanics is associated with a reduction in postoperative pulmonary complications in this high-risk population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- 是
入选标准
- •Age: 18-65 years
- •BMI ≥35 kg/m² (candidates for obesity surgery)
- •Scheduled for elective laparoscopic bariatric surgery
- •ASA physical status I-III
- •Signed informed consent
排除标准
- •Known allergy or contraindication to salbutamol
- •Severe cardiovascular disease (e.g., recent MI, uncontrolled arrhythmia)
- •Pre-existing severe pulmonary disease (e.g., severe COPD, asthma exacerbation)
- •Pregnancy or lactation
- •Emergency surgery
- •Use of β-agonists or bronchodilators within 24 hours prior to surgery
- •Patients with inability to provide informed consent
研究组 & 干预措施
Salbutamol Group
Participants in this arm will receive intraoperative salbutamol administration in addition to standard general anesthesia and mechanical ventilation during laparoscopic bariatric surgery.
干预措施: Salbutamol (Ventolin®) (Drug)
Control Group
Participants in this arm will receive intraoperative administration of normal saline (0.9% sodium chloride) via the respiratory circuit, in addition to standard general anesthesia and mechanical ventilation during laparoscopic bariatric surgery.
干预措施: Normal Saline (0.9% Sodium Chloride) (Drug)
结局指标
主要结局
Change in intraoperative mechanical power
时间窗: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)
Mechanical power will be measured directly by the ventilator/respiratory monitoring device using ventilator parameters (tidal volume, respiratory rate, peak and plateau pressures, driving pressure, and compliance) at T0, T1, and T2. The primary outcome is the difference in mechanical power between the Salbutamol and placebo groups over time.
次要结局
- Peak airway pressure (Ppeak)(Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration))
- Plateau pressure (Pplat)(Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration))
- Driving pressure (Pdrive)(Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration))
- Airway resistance (Raw)(Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration))
- Lung compliance(Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration))
- Lung elastance (E)(Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration))
- Heart rate (HR / Nabız)(Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration))
- Mean arterial pressure (MAP)(Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration))
- Postoperative pulmonary complications (Melbourne Group Scale >4)(First assessment: Within 24 hours postoperatively Second assessment: 48 hours postoperatively Third assessment: Immediately before hospital discharge)
研究者
Hülya Tosun Söner
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital