Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07378605

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionBariatric Surgery

Full registry criteria

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 \-

Treatments and study arms

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

Change in intraoperative mechanical powerBaseline (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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Health Sciences University Gazi Yaşargil Training and Research Hospital🌐 Kayapınar, Diyarbakır, Turkey (Türkiye)

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