Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-01-27 @ 3:55 AM
Study NCT ID:
NCT02272166
Status:
COMPLETED
Last Update Posted:
2017-12-21
First Post:
2014-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Propofol on Early Recovery of Hunger After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-20', 'studyFirstSubmitDate': '2014-10-15', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time before recovery of hunger after general anesthesia', 'timeFrame': '1-4 hours', 'description': 'Time before appearance of of hunger (evaluated by a score above 50/100 mm on analogic visual scale) after the end of hypnotic administration (propofol or sevoflurane).'}], 'secondaryOutcomes': [{'measure': 'Feeding comfort', 'timeFrame': '1-4 hours', 'description': 'Amount of food intake evaluated by a specific scale'}, {'measure': 'Post operative nausea and vomiting', 'timeFrame': '1-4 hours'}, {'measure': 'Validation of Chung score', 'timeFrame': '1-4 hours', 'description': 'Time needed to obtain a Chung score superior or equal to 9/10, permitting the patient to return home'}, {'measure': 'Change in plasmatic leptin level', 'timeFrame': '0-3 hours', 'description': 'Change in plasmatic leptin level (expressed in ng/ml) at the end of anesthesia, one and two hours later, compared with pre-operative value for each patient. Dosage is realized by ELISA method.'}, {'measure': 'Change in plasmatic insulin level', 'timeFrame': '0-3 hours', 'description': 'Change in plasmatic insulin level (expressed in microU/ml) at the end of anesthesia, one and two hours later, compared with pre-operative value for each patient. Dosage is realized by ELISA method.'}, {'measure': 'Change in plasmatic ghrelin level', 'timeFrame': '0-3 hours', 'description': 'Change in plasmatic ghrelin level (expressed in pg/ml) at the end of anesthesia, one and two hours later, compared with pre-operative value for each patient. Dosage is realized by ELISA method.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ambulatory Surgery', 'Anesthesia', 'Energy Expenditure', 'Food Intake']}, 'referencesModule': {'references': [{'pmid': '31997087', 'type': 'DERIVED', 'citation': 'Besnier E, Perdrix A, Gillibert A, Selim J, Froemer B, Ghemired A, Berby B, Rives N, Dureuil B, Clavier T, Compere V. Postoperative hunger after outpatient surgery in patients anesthetized with propofol vs sevoflurane: a randomized-controlled trial. Can J Anaesth. 2020 May;67(5):550-559. doi: 10.1007/s12630-020-01584-w. Epub 2020 Jan 29.'}]}, 'descriptionModule': {'briefSummary': "Recovery of hunger is a source of comfort for patients after general anesthesia. Moreover, this aspect of post-operative period is often required for discharging patients from hospital after ambulatory surgery. Indeed, this item is part of a multi-parameter score (Chung score) whose validation evaluates patient's ability to return home.\n\nThe impact of anesthetics on hunger is largely unknown but few studies suggest an orexigenic effect of propofol compared to halogenated gases. These studies had neither the power nor the methodology to answer the question. The aim of our study is to evaluate the impact of propofol versus sevoflurane on early recovery of hunger after ambulatory surgery."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-45 years old women\n* American Society of Anesthesiologists (ASA) score 1-2\n* Affiliated to a social security system\n* Undergoing an ambulatory surgery during more than 15 minutes with general anesthesia and control of upper airways (tracheal intubation or supraglottic mask or facial mask ventilation) for oocytes punction before in vitro fertilization\n* General anesthesia occuring between 8 and 10 am with respect of pre-operative fasting rules\n* APFEL risk score for nausea and vomiting ≤ 2/4\n* Ability to understand and read french\n* Signature of understood consent\n\nExclusion Criteria:\n\n* Other surgery than oocytes punction\n* Cognitive dysfunction\n* Undernutrition or risk factor of undernutrition (evolutive neoplasia, chronic alcoholism …)\n* BMI ≥ 35 kg/m²\n* Eating disorders\n* Diabetes mellitus\n* Chronic treatment with drugs modifying feeding behavior :\n\n * Benzodiazepines\n * Inhibitors of serotonin reuptake\n * Others\n* Non respect of pre-operative fasting rules\n* Indication for rapid sequence induction (gastro-oesophageal reflux, absence of gastric emptying …)\n* Contraindication to propofol (allergia to propofol, soybean or peanuts, past history of propofol infusion syndrome, unstable cardiovascular disease) or to sevoflurane (past history of malignant hyperthermia, epilepsy or liver disorders after administration of a halogenated anesthetic)\n* Pregnant or breastfeeding woman\n* Involvement in another clinical trial under 4 previous weeks'}, 'identificationModule': {'nctId': 'NCT02272166', 'acronym': 'Propo-Faim', 'briefTitle': 'Effects of Propofol on Early Recovery of Hunger After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Effects of Propofol on Early Recovery of Hunger After Ambulatory Surgery Compared With Sevoflurane', 'orgStudyIdInfo': {'id': '2014/088/HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'propofol', 'description': 'Hypnotic used in this arm is exclusively intra-venous propofol.', 'interventionNames': ['Drug: propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sevoflurane', 'description': 'Hypnotic used in this arm is exclusively inhaled sevoflurane.', 'interventionNames': ['Drug: Sevoflurane']}], 'interventions': [{'name': 'propofol', 'type': 'DRUG', 'otherNames': ['diprivan, 2,6-bis(propan-2-yl)phénol'], 'armGroupLabels': ['propofol']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Sevorane, 1,1,1,3,3,3-hexafluoro-2-(fluorométhoxy)propane'], 'armGroupLabels': ['sevoflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Bertrand Dureuil, MD-PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Departement of Anesthesia, University Hospital, Rouen'}, {'name': 'Emmanuel BESNIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departement of Anesthesia, University Hospital, Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Henri Becquerel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}