Effect of Intraoperative Salbutamol Administration on Mechanical Power and Respiratory Mechanics in Obese Patients Undergoing Laparoscopic Bariatric Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSaglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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 volunteers

Qualifiers

Age: 18-65 years

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Salbutamol (Ventolin®)

    Drug

    Salbutamol 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)

    Drug

    Normal saline will be administered intraoperatively via the respiratory circuit in the same volume and manner as salbutamol to serve as a placebo

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Salbutamol GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)

Secondary outcomes

1

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.

Time frame
Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)
2

Plateau pressure (Pplat)

Plateau pressure will be measured by the ventilator device at T0, T1, and T2 to evaluate changes in lung mechanics.

Time frame
Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)
3

Driving pressure (Pdrive)

Driving pressure (Pplat minus PEEP) will be measured via the ventilator device at all intraoperative time points to assess lung stress.

Time frame
Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)
4

Airway resistance (Raw)

Airway resistance will be recorded from the ventilator/monitoring device at each time point to evaluate intraoperative airway changes.

Time frame
Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)

Other outcomes

Sponsors and contacts

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