Effect of Intraoperative Salbutamol Administration on Mechanical Power and Respiratory Mechanics in Obese Patients Undergoing Laparoscopic Bariatric Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Salbutamol (Ventolin®), Normal Saline (0.9% Sodium Chloride).
- Who it may be relevant to
- Registry conditions: Bariatric Surgery. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Salbutamol (Ventolin®)
Salbutamol will be administered intraoperatively via the respiratory circuit during mechanical ventilation to assess its effect on mechanical power and respiratory mechanics. - Drug Normal Saline (0.9% Sodium Chloride)
Normal saline will be administered intraoperatively via the respiratory circuit in the same volume and manner as salbutamol to serve as a placebo
Primary outcome measures
- Change in intraoperative mechanical power [Time frame: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
Secondary outcome measures (9)
- Peak airway pressure (Ppeak) [Time frame: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
- Plateau pressure (Pplat) [Time frame: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
- Driving pressure (Pdrive) [Time frame: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
- Airway resistance (Raw) [Time frame: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
- Lung compliance [Time frame: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
- Lung elastance (E) [Time frame: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
- Heart rate (HR / Nabız) [Time frame: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
- Mean arterial pressure (MAP) [Time frame: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)]
- 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]
Eligibility 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
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Turkey (Türkiye) · 1 center
- Health Sciences University Gazi Yaşargil Training and Research Hospital — Kayapınar
Identifiers
NCT: NCT07378605 · Hts