Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:26 PM
Study NCT ID:
NCT07378605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-30
First Post:
2025-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intraoperative Salbutamol Administration on Mechanical Power and Respiratory Mechanics in Obese Patients Undergoing Laparoscopic Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-22', 'studyFirstSubmitDate': '2025-12-26', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in intraoperative mechanical power', 'timeFrame': 'Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Peak airway pressure (Ppeak)', 'timeFrame': 'Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)', 'description': 'Peak airway pressure will be measured directly by the ventilator/respiratory monitoring device at T0, T1, and T2 to assess intraoperative respiratory mechanics.'}, {'measure': 'Plateau pressure (Pplat)', 'timeFrame': 'Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)', 'description': 'Plateau pressure will be measured by the ventilator device at T0, T1, and T2 to evaluate changes in lung mechanics.'}, {'measure': 'Driving pressure (Pdrive)', 'timeFrame': 'Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)', 'description': 'Driving pressure (Pplat minus PEEP) will be measured via the ventilator device at all intraoperative time points to assess lung stress.'}, {'measure': 'Airway resistance (Raw)', 'timeFrame': 'Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)', 'description': 'Airway resistance will be recorded from the ventilator/monitoring device at each time point to evaluate intraoperative airway changes.'}, {'measure': 'Lung compliance', 'timeFrame': 'Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)', 'description': 'Lung compliance will be measured by the ventilator at T0, T1, and T2 to assess changes in respiratory mechanics.'}, {'measure': 'Lung elastance (E)', 'timeFrame': 'Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)', 'description': '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.'}, {'measure': 'Heart rate (HR / Nabız)', 'timeFrame': 'Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)', 'description': '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.'}, {'measure': 'Mean arterial pressure (MAP)', 'timeFrame': 'Baseline (intraoperative, after establishment of pneumoperitoneum and before Ventolin or saline administration)', 'description': '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.'}, {'measure': 'Postoperative pulmonary complications (Melbourne Group Scale >4)', 'timeFrame': 'First assessment: Within 24 hours postoperatively Second assessment: 48 hours postoperatively Third assessment: Immediately before hospital discharge', 'description': '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:\n\nTemperature \\>38°C\n\nWhite cell count \\>11.2 ×10⁹/L or use of respiratory antibiotics\n\nPhysician diagnosis of pneumonia or chest infection\n\nChest X-ray findings of atelectasis or consolidation\n\nProduction of purulent (yellow/green) sputum different from preoperative sputum\n\nPositive microbiological analysis of sputum\n\nSpO₂ \\<90% in ambient air\n\nRe-admission to or prolonged stay (\\>36 h) in ICU/high dependency unit for respiratory problems\n\nPatients meeting ≥4 of these criteria at any assessment point will be recorded as having a postoperative pulmonary complication.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery']}, 'descriptionModule': {'briefSummary': '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.\n\nSecondary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-65 years\n\nBMI ≥35 kg/m² (candidates for obesity surgery)\n\nScheduled for elective laparoscopic bariatric surgery\n\nASA physical status I-III\n\nSigned informed consent\n\nExclusion Criteria:\n\nKnown allergy or contraindication to salbutamol\n\nSevere cardiovascular disease (e.g., recent MI, uncontrolled arrhythmia)\n\nPre-existing severe pulmonary disease (e.g., severe COPD, asthma exacerbation)\n\nPregnancy or lactation\n\nEmergency surgery\n\nUse of β-agonists or bronchodilators within 24 hours prior to surgery\n\nPatients with inability to provide informed consent\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07378605', 'acronym': 'Bariatric', 'briefTitle': 'Effect of Intraoperative Salbutamol Administration on Mechanical Power and Respiratory Mechanics in Obese Patients Undergoing Laparoscopic Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital'}, 'officialTitle': 'Effect of Intraoperative Salbutamol Administration on Mechanical Power and Respiratory Mechanics in Obese Patients Undergoing Laparoscopic Bariatric Surgery', 'orgStudyIdInfo': {'id': 'Hts'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Salbutamol Group', 'description': 'Participants in this arm will receive intraoperative salbutamol administration in addition to standard general anesthesia and mechanical ventilation during laparoscopic bariatric surgery.', 'interventionNames': ['Drug: Salbutamol (Ventolin®)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': '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.', 'interventionNames': ['Drug: Normal Saline (0.9% Sodium Chloride)']}], 'interventions': [{'name': 'Salbutamol (Ventolin®)', 'type': 'DRUG', 'description': 'Salbutamol will be administered intraoperatively via the respiratory circuit during mechanical ventilation to assess its effect on mechanical power and respiratory mechanics.', 'armGroupLabels': ['Salbutamol Group']}, {'name': 'Normal Saline (0.9% Sodium Chloride)', 'type': 'DRUG', 'description': 'Normal saline will be administered intraoperatively via the respiratory circuit in the same volume and manner as salbutamol to serve as a placebo', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kayapınar', 'state': 'Diyarbakır', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'hülya tosun söner', 'role': 'CONTACT', 'email': 'hulyatosunsoner@hotmail.com', 'phone': '05352792102'}], 'facility': 'Health Sciences University Gazi Yaşargil Training and Research Hospital', 'geoPoint': {'lat': 37.93733, 'lon': 40.17756}}], 'centralContacts': [{'name': 'hülya tosun söner', 'role': 'CONTACT', 'email': 'hulyatosunsoner@hotmail.com', 'phone': '+905352792102'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital', 'investigatorFullName': 'Hülya Tosun Söner', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital'}}}}