Bariatric SurgeryBariatricNCT07378605
Effect of Intraoperative Salbutamol Administration on Mechanical Power and Respiratory Mechanics in Obese Patients Undergoing Laparoscopic Bariatric Surgery
A study testing Salbutamol (Ventolin®) and Normal Saline (0.9% Sodium Chloride) in people with Bariatric Surgery, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Salbutamol (Ventolin®) and Normal Saline (0.9% Sodium Chloride)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Health Sciences University Gazi Yaşargil Training and Research Hospital
Kayapınar, Diyarbakır
hülya tosun söner, 05352792102, hulyatosunsoner@hotmail.com
About this study
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
- Being tested
- Salbutamol (Ventolin®), Normal Saline (0.9% Sodium Chloride)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Normal Saline (0.9% Sodium Chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)
Secondary outcomes (9)
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.
Measured: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)
Plateau pressure (Pplat)
Plateau pressure will be measured by the ventilator device at T0, T1, and T2 to evaluate changes in lung mechanics.
Measured: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)
Driving pressure (Pdrive)
Driving pressure (Pplat minus PEEP) will be measured via the ventilator device at all intraoperative time points to assess lung stress.
Measured: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)
Airway resistance (Raw)
Airway resistance will be recorded from the ventilator/monitoring device at each time point to evaluate intraoperative airway changes.
Measured: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)
Lung compliance
Lung compliance will be measured by the ventilator at T0, T1, and T2 to assess changes in respiratory mechanics.
Measured: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)
Lung elastance (E)
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.
Measured: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)
Heart rate (HR / Nabız)
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.
Measured: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)
Mean arterial pressure (MAP)
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.
Measured: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)
Postoperative pulmonary complications (Melbourne Group Scale >4)
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.
Measured: First assessment: Within 24 hours postoperatively Second assessment: 48 hours postoperatively Third assessment: Immediately before hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya Tosun Söner, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378605
- Sponsor's protocol ID
- Hts
- Acronym
- Bariatric
- Status last verified
- Jan 2026
- First submitted
- 26 Dec 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Salbutamol Administration on Mechanical Power and Respiratory Mechanics in Obese Patients Undergoing Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07378605
- Acronym / sponsor ID
- Bariatric / Hts
- Conditions
- Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salbutamol Group | Experimental | Drug: Salbutamol (Ventolin®)Participants in this arm will receive intraoperative salbutamol administration in addition to standard general anesthesia and mechanical ventilation during laparoscopic bariatric surgery. |
| Control Group | Placebo comparator | Drug: Normal Saline (0.9% Sodium Chloride)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Salbutamol Group |
| 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 | Drug | Control Group |
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salbutamol (Ventolin®) and Normal Saline (0.9% Sodium Chloride) in people with Bariatric Surgery, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hülya tosun söner (+905352792102, hulyatosunsoner@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intraoperative mechanical power (time frame: Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.