Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-03-10 @ 11:51 PM
Study NCT ID:
NCT06681805
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2024-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Mirtazapine and Different Doses of Intrathecal Morphine in Preventing Nausea and Vomiting After Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078785', 'term': 'Mirtazapine'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2024-11-05', 'studyFirstSubmitQcDate': '2024-11-07', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postoperative nausea and vomiting', 'timeFrame': '24 hours postoperatively', 'description': 'Incidence of postoperative nausea and vomiting was recorded at 3, 6, 12, 18, 24 hours postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Degree of pain', 'timeFrame': '24 hours postoperatively', 'description': 'Each patient was instructed about postoperative pain assessment with the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS was assessed at 0, 3, 6, 12, 18, 24 hours postoperatively.'}, {'measure': 'Time to first rescue analgesia', 'timeFrame': '24 hours postoperatively', 'description': 'Time to the first request for the rescue analgesia (time from the end of surgery to the first dose of pethidine administrated).'}, {'measure': 'Total pethidine consumption', 'timeFrame': '24 hours postoperatively', 'description': 'Rescue analgesia of pethidine 0.5μg/kg was given as a bolus if the numeric rating scale (NRS) \\> 3.'}, {'measure': 'Incidence of adverse events', 'timeFrame': '24 hours postoperatively', 'description': 'Incidence of adverse events such as itching, bradycardia, hypotension, pruritis, urinary retention, headache, respiratory depression, miosis, and seizures were recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prophylactic', 'Mirtazapine', 'Intrathecal', 'Morphine', 'Nausea', 'Vomiting']}, 'descriptionModule': {'briefSummary': 'The aim of this work was to evaluate the role of prophylactic mirtazapine and different doses of intrathecal morphine in preventing nausea and vomiting.', 'detailedDescription': 'It is common practice to provide intrathecal morphine to alleviate postoperative pain because of its powerful and long-lasting analgesic effects. Mirtazapine is a noradrenergic and specific serotonergic antidepressant. It is anxiolytic by its antagonist of the 5HT2 receptor and is strongly sleep-inducing. Its antagonist at 5-hydroxytryptamine subtype 3 (5-HT3) receptor may help to prevent nausea and vomiting'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women scheduled for a cesarean section', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-40 years.\n* American Society of Anesthesiologists (ASA) physical status I-II.\n* Scheduled for caesarean section under spinal anesthesia\n\nExclusion Criteria:\n\n* Known hypersensitivity to mirtazapine.\n* Gastrointestinal illness.\n* Diabetes mellitus.\n* Use of opioids or any medication with known antiemetic properties within 48 hours before surgery.\n* Mental disorders.\n* Spinal anesthesia contraindications.\n* Taking antidepressants or antipsychotic medications.'}, 'identificationModule': {'nctId': 'NCT06681805', 'briefTitle': 'Prophylactic Mirtazapine and Different Doses of Intrathecal Morphine in Preventing Nausea and Vomiting After Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Role of Prophylactic Mirtazapine and Different Doses of Intrathecal Morphine in Preventing Nausea and Vomiting After Cesarean Section: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '36264PR752/7/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Groups I', 'description': 'Patients received 30mg of oral mirtazapine one hour before surgery plus 10 mg of bupivacaine 0.5% along with 0.2 mg of morphine.', 'interventionNames': ['Drug: Mirtazapine + Bupivacaine + Morphine']}, {'type': 'EXPERIMENTAL', 'label': 'Groups II', 'description': 'Patients received 30mg of oral mirtazapine one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.1 mg of morphine.', 'interventionNames': ['Drug: Mirtazapine + Bupivacaine + Morphine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Groups III', 'description': 'Patients received a placebo one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.2 mg of morphine.', 'interventionNames': ['Drug: Placebo + Bupivacaine + Morphine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Groups IV', 'description': 'Patients received a placebo one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.1 mg of morphine.', 'interventionNames': ['Drug: Placebo+ Bupivacaine + Morphine']}], 'interventions': [{'name': 'Mirtazapine + Bupivacaine + Morphine', 'type': 'DRUG', 'description': 'Patients received 30mg of oral mirtazapine one hour before surgery plus 10 mg of bupivacaine 0.5% along with 0.2 mg of morphine.', 'armGroupLabels': ['Groups I']}, {'name': 'Mirtazapine + Bupivacaine + Morphine', 'type': 'DRUG', 'description': 'Patients received 30mg of oral mirtazapine one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.1 mg of morphine.', 'armGroupLabels': ['Groups II']}, {'name': 'Placebo + Bupivacaine + Morphine', 'type': 'DRUG', 'description': 'Patients received a placebo one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.2 mg of morphine.', 'armGroupLabels': ['Groups III']}, {'name': 'Placebo+ Bupivacaine + Morphine', 'type': 'DRUG', 'description': 'Patients received a placebo one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.1 mg of morphine.', 'armGroupLabels': ['Groups IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33516', 'city': 'Kafr ash Shaykh', 'state': 'Kafrelsheikh', 'country': 'Egypt', 'facility': 'Kafrelsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelshiekh University, Kafrelshiekh, Egypt', 'investigatorFullName': 'Basma Mohamed Ghoniem', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}