Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT07295158
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Sevoflurane vs Desflurane on Mechanical Power in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D000077335', 'term': 'Desflurane'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D005019', 'term': 'Ethyl Ethers'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and postoperative outcome assessors are masked to group allocation. The anesthesia team administering sevoflurane or desflurane is not blinded, but all intraoperative data collectors and postoperative evaluators remain blinded to the inhalational agent used. Randomization is performed using sealed opaque envelopes to maintain allocation concealment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 138}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-12-08', 'studyFirstSubmitQcDate': '2025-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mechanical Power (MP) during General Anesthesia', 'timeFrame': 'Measured at three intraoperative time points: Post-intubation baseline (MP1) 15 minutes after pneumoperitoneum (MP2) End of surgery before emergence (MP3)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perioperative Respiratory Mechanics']}, 'referencesModule': {'references': [{'pmid': '36836435', 'type': 'BACKGROUND', 'citation': 'Jo YY, Chang YJ, Lee D, Kim YB, Jung J, Kwak HJ. Comparisons of Mechanical Power and Respiratory Mechanics in Pressure-Controlled Ventilation and Volume-Controlled Ventilation during Laparoscopic Cholecystectomy in Elderly Patients. J Pers Med. 2023 Jan 23;13(2):201. doi: 10.3390/jpm13020201.'}]}, 'descriptionModule': {'briefSummary': 'This single-center, prospective, randomized, assessor-blinded clinical trial aims to compare the effects of sevoflurane and desflurane anesthesia on intraoperative mechanical power in adult patients undergoing elective laparoscopic cholecystectomy. Mechanical power will be measured at three standardized time points using a validated formula, and secondary outcomes include driving pressure values and early postoperative respiratory complications (desaturation, laryngospasm, bronchospasm, cough).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-65 years\n\nASA Physical Status I-II\n\nScheduled for elective laparoscopic cholecystectomy\n\nAble to provide written informed consent\n\nExclusion Criteria:\n\nKnown hypersensitivity or contraindication to study medications (sevoflurane or desflurane)\n\nSevere chronic obstructive pulmonary disease (COPD)\n\nUncontrolled bronchial asthma\n\nDecompensated heart failure (NYHA Class III-IV)\n\nHistory of prior lung surgery\n\nMorbid obesity (BMI \\> 35 kg/m²)\n\nPregnancy\n\nRefusal to participate or inability to provide informed consent\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07295158', 'acronym': 'VAPOR', 'briefTitle': 'Effect of Sevoflurane vs Desflurane on Mechanical Power in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Konya City Hospital'}, 'officialTitle': 'Laparoscopic Cholecystectomy Patients: Effect of Sevoflurane vs. Desflurane on Mechanical Power - A Prospective, Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'LC-MP-2025-01"'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm S- Sevoflurane Group', 'description': 'Maintenance of general anesthesia with sevoflurane 2% during laparoscopic cholecystectomy. Mechanical power is measured at three intraoperative time points using standardized ventilator settings.', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D-desflurane group', 'description': 'Maintenance of general anesthesia with desflurane 6% during laparoscopic cholecystectomy. Mechanical power is measured at three standardized intraoperative time points under identical ventilator settings.', 'interventionNames': ['Drug: Desflurane']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Group S'], 'description': 'General anesthesia will be maintained with sevoflurane at 2% concentration in patients assigned to the Sevoflurane Group (Group S). Standardized ventilator settings will be applied for all participants, and mechanical power will be measured at three intraoperative time points while sevoflurane is used as the sole maintenance inhalational agent.', 'armGroupLabels': ['Arm S- Sevoflurane Group']}, {'name': 'Desflurane', 'type': 'DRUG', 'description': 'Maintenance of general anesthesia with desflurane 6% during laparoscopic cholecystectomy. Mechanical power is measured at three intraoperative time points using standardized ventilator settings.', 'armGroupLabels': ['Arm D-desflurane group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nuran AKINCI EKİNCİ', 'role': 'CONTACT', 'email': 'nurandr@yahoo.com', 'phone': '+905337637180'}, {'name': 'Esma Karaarslan', 'role': 'CONTACT', 'phone': '+905057317061'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya City Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist in Anesthesiology and Reanimation', 'investigatorFullName': 'Nuran Akıncı Ekinci', 'investigatorAffiliation': 'Konya City Hospital'}}}}