Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-31 @ 5:25 AM
Study NCT ID:
NCT05262933
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2022-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Preoperative Coffee Consumption in Cesarean Sections Under Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051299', 'term': 'Post-Dural Puncture Headache'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003069', 'term': 'Coffee'}, {'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-14', 'studyFirstSubmitDate': '2022-02-21', 'studyFirstSubmitQcDate': '2022-02-21', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hypotension', 'timeFrame': 'intraoperative time period', 'description': 'effects of orally coffee intake on spinal anesthesia induced hypotension'}], 'secondaryOutcomes': [{'measure': 'Post-dural puncture headache', 'timeFrame': 'post operative 3 days', 'description': 'Effects of orally coffee intake on postdural puncture headache'}, {'measure': 'intestinal motility, first flatus', 'timeFrame': 'post operative 3 days', 'description': 'Effects of orally coffee intake on postoperative intestinal motility'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypotension After Spinal Anesthesia', 'Post-Dural Puncture Headache']}, 'descriptionModule': {'briefSummary': "The prospective study is planned in a university hospital. Spinal anesthesia is widely used for cesarean section currently for its safety, low cost, reliability, easiness to administer, immediate effect, and well-operating conditions. However spinal anesthesia has some complications as hypotension, bradycardia and Post Dural Puncture Headache (PDPH). A practical strategy for avoiding hypotension during initiation of spinal anesthesia for cesarean delivery includes intravenous crystalloid, in conjunction with administration of vasopressors. PDPH is one of the most frequent complications of spinal anesthesia. Conservative therapies such as bed rest, hydration, and caffeine are commonly used as management. For this study, coffee group of patients will be given unsweetened brewed coffee 150 ml until 2-4 hours before surgery. Patients who accept to drink brewed coffee ( coffee group) and water( control group) will be included in the study. The patient's heart rate, blood pressure, oxygen saturation will be monitored and recorded during operation. Intraoperative will be recorded to amount of vasopressor and intraveous crystalloid. Whether the patient develops PDPH in the postoperative period will be followed for 3 days. In addition abdominal auscultation for bowel sounds hourly and the time of first bowel movements will be recorded. According to the patient's statement, the time of first flatulence and defecation will be followed and recorded."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'parturient women aged 18-45', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who accept to participate in the study\n* patient who limit the consumption of caffeinated beverages such as coffee and tea during pregnancy\n* Patients with known caffeine or coffee allergy\n\nExclusion Criteria:\n\n* patients who refuse to participate in the study\n* Patients with known cardiovascular disease\n* Patients with known cerebrovascular disease\n* patients with known neurological, neurodegenerative or psychiatric disease\n* patients with known liver failure\n* patient followed up with eclampsia and preaclampsi\n* higher number of needle passes in spinal anesthesia\n* patients treated with an antiemetic'}, 'identificationModule': {'nctId': 'NCT05262933', 'briefTitle': 'Effects of Preoperative Coffee Consumption in Cesarean Sections Under Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Effect of Preoperative Coffee Consumption on Intraoperative and Post Operative Outcomes in Cesarean Section With Spinal Anesthesia', 'orgStudyIdInfo': {'id': '2021/825'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'coffee (n= 70)', 'description': 'Patients are planned to drink brewed coffee 2 hours before surgery.', 'interventionNames': ['Other: coffee']}, {'label': 'control (n=70)', 'description': 'Patients are planned to drink water 2 hours before surgery.', 'interventionNames': ['Other: Water']}], 'interventions': [{'name': 'coffee', 'type': 'OTHER', 'otherNames': ['It will be given to patients brewed coffee to drink'], 'description': 'It will be given to patients brewed coffee to drink and evaluated to hypotension and post spinal puncture headache', 'armGroupLabels': ['coffee (n= 70)']}, {'name': 'Water', 'type': 'OTHER', 'otherNames': ['It will be given to patients water to drink'], 'description': 'It will be given to patients water to drink and evaluated to hypotension and post spinal puncture headache', 'armGroupLabels': ['control (n=70)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Gamze Talih', 'investigatorAffiliation': 'TC Erciyes University'}}}}