About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age: 18-65 years
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Salbutamol (Ventolin®)
DrugSalbutamol will be administered intraoperatively via the respiratory circuit during mechanical ventilation to assess its effect on mechanical power and respiratory mechanics.
Normal Saline (0.9% Sodium Chloride)
DrugNormal saline will be administered intraoperatively via the respiratory circuit in the same volume and manner as salbutamol to serve as a placebo
Treatment groups
Trial outcomes
Primary outcomes
Change in intraoperative mechanical power
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.
Secondary outcomes
Peak airway pressure (Ppeak)
Peak airway pressure will be measured directly by the ventilator/respiratory monitoring device at T0, T1, and T2 to assess intraoperative respiratory mechanics.
Plateau pressure (Pplat)
Plateau pressure will be measured by the ventilator device at T0, T1, and T2 to evaluate changes in lung mechanics.
Driving pressure (Pdrive)
Driving pressure (Pplat minus PEEP) will be measured via the ventilator device at all intraoperative time points to assess lung stress.
Airway resistance (Raw)
Airway resistance will be recorded from the ventilator/monitoring device at each time point to evaluate intraoperative airway changes.
Sponsors and contacts
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