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

NCT07378605 | Not Yet Recruiting

• 1 other identifier: Hts
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgery

Outcome Measures

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.

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

Secondary Outcomes (9)

• Peak airway pressure (Ppeak)

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

• Plateau pressure (Pplat)

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

• Driving pressure (Pdrive)

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

• Airway resistance (Raw)

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

• Lung compliance

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

Study Arms (2)

Salbutamol Group

EXPERIMENTAL

Participants in this arm will receive intraoperative salbutamol administration in addition to standard general anesthesia and mechanical ventilation during laparoscopic bariatric surgery.

Drug: Salbutamol (Ventolin®)

Control Group

PLACEBO COMPARATOR

Participants in this arm will receive intraoperative administration of normal saline (0.9% sodium chloride) via the respiratory circuit, in addition to standard general anesthesia and mechanical ventilation during laparoscopic bariatric surgery.

Drug: Normal Saline (0.9% Sodium Chloride)

Interventions

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.

Salbutamol Group

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

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Health Sciences University Gazi Yaşargil Training and Research Hospital

Kayapınar, Diyarbakır, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Albuterol; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

hülya tosun söner

CONTACT

+905352792102; hulyatosunsoner@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 30, 2026
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 15, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)