Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT04397393
Status:
TERMINATED
Last Update Posted:
2020-12-11
First Post:
2020-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'insufficient data', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2020-05-17', 'studyFirstSubmitQcDate': '2020-05-20', 'lastUpdatePostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform the OPU', 'timeFrame': '1 day', 'description': 'Mean dosage of Midazolam for both groups (Camel milk consumption vs no camel milk consumption'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia', 'IVF']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fao.org/3/X6528E/X6528E03.htm#chIII.', 'label': 'Consumption of Camel Milk'}, {'url': 'http://www.fao.org/3/X6528E/X6528E11.htm', 'label': 'Gast, M., Mauboisj, L. and Adda, J. Le lait et les produits laitiers en Ahaggar. Centr. Rech. Anthr. Prehist. Ethn. 1969'}, {'url': 'http://www.fao.org/3/X6528E/X6528E11.htm', 'label': 'Kuchabaev, K.A. Cherepanova, V.P. and Panomarev P.P. Feeding, milk productivity and chemical composition of camel milk. : 58-62, 1972.El-Bahay, 1962'}, {'url': 'http://www.fao.org/3/X6528E/X6528E11.htm', 'label': 'Kon, S.K. Milk and milk products for human nutrition. FAO Nutrition Serv. 7, p. 6, 1959 (Revised in 1972)., Knoess, K.H. Milk production of the dromedary. In: Camels. IFS Symposium, Sudan. 201-214, 1979'}, {'url': 'http://www.fao.org/3/X6528E/X6528E11.htm', 'label': 'Dhingra, D.R. The component fatty acid and glycerides of the milk fats of Indian goats and sheep. Biochem. J. 27: 851-859, 1933'}, {'url': 'http://www.fao.org/3/X6528E/X6528E11.htm', 'label': 'Dhingra, D.R. Fatty acids and glycerides of the milk fat of camels. Biochem. J. 28: 73-78, 1934'}, {'url': 'http://www.fao.org/3/X6528E/X6528E11.htm', 'label': 'Ohris, S.P. and Joshi, B.K. Composition of camel milk. Indian Vet. J. 38(a): 514-516, 1961; 38(b): 604-606, 1961'}, {'url': 'http://www.fao.org/3/X6528E/X6528E11.htm', 'label': 'Epstein, H. The origin of the domestic animals of Africa. Vol. 2. New York. Africiana Publ. Corp. Leipzig. Edition Leipzig. 1971'}]}, 'descriptionModule': {'briefSummary': 'The primary aim is to verify if camel milk consumption has an impact on the amount of Midazolam needed to achieve a satisfactory level of sedation for oocyte retrieval, compared to patients never having consumed camel milk.', 'detailedDescription': 'A pilot study will be performed on patients undergoing oocyte retrieval (OPU) for the first time, and correlated to camel milk consumption versus never consumed camel milk, as well as age, BMI (body mass index), number of follicles at the time of OPU, number of previous OPUs in other clinics, previous vaginal delivery, past medical history positive for chemo therapy, alcohol consumption, use of prescribed or illicit drugs, or chronic pain medication.\n\nThe main objective is to analyse if the consumption of camel milk, the frequency, or lack thereof correlates with the amount of the sedative drug Midazolam needed to achieve an acceptable level of sedation in order to estimate the dosage needed in both patient groups more adequately, reducing either discomfort felt at a too low an initial dosage, as well as avoiding a deeper level of sedation than needed with subsequent prolonged stay in recovery and unpleasant feelings of dizziness and drowsiness, potentially requiring antagonizing Midazolam by the use of Flumazenil, and reducing overall costs and length of stay in recovery and bed occupancy and enhancing patient experience and satisfaction.\n\nWould this study enable the Investigators to determine further effect of camel milk on other drugs used for various other purposes, and lead to a change in dose regimen?'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'population is defined by all females of Arab origin, booked for oocyte retrieval for the first time in our center', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Arab origin\n* Female 18 -48 years of age\n* BMI \\< 37 kg/m2\n* All ovarian stimulation protocols\n\nExclusion Criteria:\n\n* Previous oocyte retrieval at our center\n* Post chemo therapy\n* Illicit drug use\n* Chronic pain medication\n* Medication which is known to increase the activity of liver enzymes\n* Any alcohol consumption\n* Previous vaginal delivery'}, 'identificationModule': {'nctId': 'NCT04397393', 'briefTitle': 'Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation', 'organization': {'class': 'OTHER', 'fullName': 'ART Fertility Clinics LLC'}, 'officialTitle': 'Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation: A Pilot Study', 'orgStudyIdInfo': {'id': '1910-ABU-090-NE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-camel milk consumption', 'description': 'non-camel milk consumption over life time', 'interventionNames': ['Drug: Midazolam']}, {'label': 'camel milk consumption', 'description': 'camel milk consumption at least once during lifetime, with 2 subgroups of camel milk consumption: once, twice, three times; as well as regularly (daily, once per week, once per month, once per year).', 'interventionNames': ['Drug: Midazolam']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'description': 'Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform OPU', 'armGroupLabels': ['camel milk consumption', 'non-camel milk consumption']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60202', 'city': 'Abu Dhabi', 'country': 'United Arab Emirates', 'facility': 'IVI Middle East Fertility Clinic', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'overallOfficials': [{'name': 'Nils Engelmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVI Middle East Fertility Clinic LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ART Fertility Clinics LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesia Consultant', 'investigatorFullName': 'Nils Engelmann', 'investigatorAffiliation': 'ART Fertility Clinics LLC'}}}}