Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2026-02-13 @ 11:45 AM
Study NCT ID:
NCT02220361
Status:
UNKNOWN
Last Update Posted:
2014-09-30
First Post:
2014-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine on Prevention of Side Effects of Hemabate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-28', 'studyFirstSubmitDate': '2014-08-14', 'studyFirstSubmitQcDate': '2014-08-18', 'lastUpdatePostDateStruct': {'date': '2014-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SpO2 Change', 'timeFrame': 'participants will be followed for the duration of surgery, an expected average of 2 hours'}, {'measure': 'systolic blood pressure and diastolic blood pressure change', 'timeFrame': 'participants will be followed for the duration of surgery, an expected average of 2 hours'}, {'measure': 'Heart rate change', 'timeFrame': 'participants will be followed for the duration of surgery, an expected average of 2 hours'}, {'measure': 'nausea', 'timeFrame': '24 h postoperatively'}, {'measure': 'vomiting', 'timeFrame': '24h postoperatively'}, {'measure': 'fever', 'timeFrame': '24h postoperatively'}, {'measure': 'diarrhea', 'timeFrame': '24h postoperatively'}, {'measure': 'headache', 'timeFrame': '24h postoperatively'}, {'measure': 'elevated blood pressure', 'timeFrame': '24h postoperatively'}, {'measure': 'chest congestion', 'timeFrame': '24h postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gynecological Patient']}, 'descriptionModule': {'briefSummary': 'Hemabate is often used for gynecological patients. Hemabate is associated with many side effects, including a burning sensation in the stomach, nausea, vomiting, diarrhea etc. It is reported that dexmedetomidine reduce gastrointestinal reaction during perioperative period. We design this clinical trial to find if dexmedetomidine can prevent the side effects of hemabate in Cesarean Section patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\ngynecological patients\n\nExclusion Criteria:\n\n* Neuromuscular and endocrine diseases\n* Allergic reactions to a2-adrenergic agonist\n* Previous abdominal surgery including prior caesarean section.'}, 'identificationModule': {'nctId': 'NCT02220361', 'briefTitle': 'Dexmedetomidine on Prevention of Side Effects of Hemabate', 'organization': {'class': 'OTHER', 'fullName': "Guangzhou Women and Children's Medical Center"}, 'officialTitle': 'Phase 4 Study of Effects of Dexmedetomidine on Prevention of Side Effects of Hemabate in Cesarean Section Patients', 'orgStudyIdInfo': {'id': 'JNi'}, 'secondaryIdInfos': [{'id': 'DAGZWCMC', 'type': 'OTHER', 'domain': "Department of Anesthesiology,Guangzhou Women and Children's Medical Center"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'received 20 ml intravenous physiological saline', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'low dose dexmedetomidine group', 'description': 'received 0.5μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline', 'interventionNames': ['Drug: low dose dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'hemabate+high dose dexmedetomidine group', 'description': 'received 1μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline', 'interventionNames': ['Drug: high dose dexmedetomidine']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'received 20 ml intravenous physiological saline The infusion were completed in 30 minutes.', 'armGroupLabels': ['placebo group']}, {'name': 'low dose dexmedetomidine', 'type': 'DRUG', 'description': 'received 0.5μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline The infusion were completed in 30 minutes.', 'armGroupLabels': ['low dose dexmedetomidine group']}, {'name': 'high dose dexmedetomidine', 'type': 'DRUG', 'description': 'received 1μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline.\n\nThe infusion was completed in 30 minutes', 'armGroupLabels': ['hemabate+high dose dexmedetomidine group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jin Ni', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Department of Anesthesiology', 'investigatorFullName': 'Jin Ni', 'investigatorAffiliation': "Guangzhou Women and Children's Medical Center"}}}}