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NCT Number: NCT07378605

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences University Gazi Yaşargil Training and Research Hospital

Kayapınar, Diyarbakır, Turkey (Türkiye)

Location contact

hülya tosun söner

CONTACT

[email protected]

05352792102

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

-

Treatment and study plan

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

Primary outcomes

  1. Change in intraoperative mechanical power

    Time frame: 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.

Secondary outcomes

  1. Peak airway pressure (Ppeak)

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

    Peak airway pressure will be measured directly by the ventilator/respiratory monitoring device at T0, T1, and T2 to assess intraoperative respiratory mechanics.

  2. Plateau pressure (Pplat)

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

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

  3. Driving pressure (Pdrive)

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

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

  4. Airway resistance (Raw)

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

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

  5. Lung compliance

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

    Lung compliance will be measured by the ventilator at T0, T1, and T2 to assess changes in respiratory mechanics.

  6. Lung elastance (E)

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

    Lung elastance will be measured directly by the ventilator/monitoring device at each intraoperative time point (T0, T1, T2) to evaluate the stiffness of the respiratory system and its changes due to pneumoperitoneum and Ventolin/SF administration.

  7. Heart rate (HR / Nabız)

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

    Heart rate will be monitored continuously and recorded at T0, T1, and T2 to evaluate intraoperative hemodynamic stability and potential effects of pneumoperitoneum and Ventolin/SF administration.

  8. Mean arterial pressure (MAP)

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

    Mean arterial pressure will be monitored continuously and recorded at T0, T1, and T2 to assess intraoperative hemodynamic stability and the effects of pneumoperitoneum and Ventolin/SF administration.

  9. Postoperative pulmonary complications (Melbourne Group Scale >4)

    Time frame: First assessment: Within 24 hours postoperatively Second assessment: 48 hours postoperatively Third assessment: Immediately before hospital discharge

    Incidence of postoperative pulmonary complications will be assessed using the Melbourne Group Scale (MGS). A score greater than 4 indicates the presence of a postoperative pulmonary complication. Criteria include:

    Temperature >38°C

    White cell count >11.2 ×10⁹/L or use of respiratory antibiotics

    Physician diagnosis of pneumonia or chest infection

    Chest X-ray findings of atelectasis or consolidation

    Production of purulent (yellow/green) sputum different from preoperative sputum

    Positive microbiological analysis of sputum

    SpO₂ <90% in ambient air

    Re-admission to or prolonged stay (>36 h) in ICU/high dependency unit for respiratory problems

    Patients meeting ≥4 of these criteria at any assessment point will be recorded as having a postoperative pulmonary complication.

Study contacts

Contact information is provided by the study sponsor or research team.

hülya tosun söner

CONTACT

[email protected]

+905352792102

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Acronym: Bariatric

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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