Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT03417518
Status:
COMPLETED
Last Update Posted:
2018-02-09
First Post:
2018-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Anesthesia With Propofol Versus Desflurane in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077335', 'term': 'Desflurane'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D005019', 'term': 'Ethyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-08', 'studyFirstSubmitDate': '2018-01-25', 'studyFirstSubmitQcDate': '2018-01-25', 'lastUpdatePostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Malondialdehyde (MDA) level in blood sample', 'timeFrame': 'up to 24 hours post bariatric surgery', 'description': 'Plasma MDA level is measured as an oxidative stress marker before the surgery, at 1 hour, 2 hours, 24 hours post-surgical incision.'}], 'secondaryOutcomes': [{'measure': 'C-Reactive Protein (CRP) in blood sample', 'timeFrame': 'up to 24 hours post bariatric surgery', 'description': 'Plasma CRP level is measured as an inflammation marker before the surgery, at 1 hour, 2 hours, 24 hours post-surgical incision.'}, {'measure': 'Monocyte level in blood sample', 'timeFrame': 'up to 24 hours post bariatric surgery', 'description': 'Monocyte level is measured as an inflammation marker before the surgery, at 1 hour, 2 hours, 24 hours post-surgical incision.'}, {'measure': 'Pain assessed by Visual Analog Scale (VAS)', 'timeFrame': 'up to 48 hours after surgery', 'description': 'Pain level is determined at 2 hours, 24 hours and 48 hours post-surgical incision. Visual analog pain score (scale = 0 no pain; 10= worst pain imaginable)'}, {'measure': 'Side-effects (nausea, vomiting, somnolence, respiratory depression)', 'timeFrame': 'up to 48 hours after surgery', 'description': 'Evaluation at 2 hours, 24 hours and 48 hours post-surgical incision'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oxidative stress', 'Bariatric surgery'], 'conditions': ['Anesthesia', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '18298345', 'type': 'BACKGROUND', 'citation': 'Skalicky J, Muzakova V, Kandar R, Meloun M, Rousar T, Palicka V. Evaluation of oxidative stress and inflammation in obese adults with metabolic syndrome. Clin Chem Lab Med. 2008;46(4):499-505. doi: 10.1515/CCLM.2008.096.'}, {'pmid': '16054557', 'type': 'BACKGROUND', 'citation': 'Del Rio D, Stewart AJ, Pellegrini N. A review of recent studies on malondialdehyde as toxic molecule and biological marker of oxidative stress. Nutr Metab Cardiovasc Dis. 2005 Aug;15(4):316-28. doi: 10.1016/j.numecd.2005.05.003.'}, {'pmid': '1319189', 'type': 'BACKGROUND', 'citation': 'Murphy PG, Myers DS, Davies MJ, Webster NR, Jones JG. The antioxidant potential of propofol (2,6-diisopropylphenol). Br J Anaesth. 1992 Jun;68(6):613-8. doi: 10.1093/bja/68.6.613.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the effects of propofol compared with desflurane on oxidative stress and inflammation markers in obese patients undergoing scheduled bariatric surgery.', 'detailedDescription': 'Obese patients have a high level of oxidative stress and inflammation activity. Desflurane is an anesthetic gas often used for obese patients. Propofol, another anesthetic agent, has shown an antioxidant property. The aim of the study is to compare the effects of propofol with desflurane on oxidative stress and inflammation markers in obese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) \\>35\n* scheduled gastric by pass surgery\n* American Society of Anesthesiologists (ASA) \\<III\n\nExclusion Criteria:\n\n* Allergic to anesthesia agent\n* patient refusal'}, 'identificationModule': {'nctId': 'NCT03417518', 'briefTitle': 'Effects of Anesthesia With Propofol Versus Desflurane in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Saint Pierre'}, 'officialTitle': 'Effects of General Anesthesia With Propofol Versus Desflurane on Oxidative Stress and Inflammation in Obese Patients Scheduled for Bariatric Surgery', 'orgStudyIdInfo': {'id': 'B076201420067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Desflurane Inhalant Product Group', 'description': 'general anesthesia with desflurane', 'interventionNames': ['Drug: Desflurane Inhalant Product']}, {'type': 'EXPERIMENTAL', 'label': 'Propofol Group', 'description': 'general anesthesia with propofol', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Desflurane Inhalant Product', 'type': 'DRUG', 'otherNames': ['Suprane'], 'description': 'General anesthesia will be induced with sufentanyl (0.2µg/kg) and thiopental (5mg/kg) and maintained by desflurane', 'armGroupLabels': ['Desflurane Inhalant Product Group']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Diprivan'], 'description': 'General anesthesia will be induced with propofol (2mg/kg) and sufentanyl (0.2µg/kg) and maintained by propofol in a target-controlled infusion mode', 'armGroupLabels': ['Propofol Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Panayota Kapessidou', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Saint-Pierre (CHU Saint-Pierre), Universite libre de Bruxelles (ULB)'}, {'name': 'Livia Di Marco, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Saint-Pierre (CHU Saint-Pierre)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Saint Pierre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}