Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT01412632
Status:
COMPLETED
Last Update Posted:
2014-10-01
First Post:
2011-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Two Types of Sedation to Gynaecological Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-03-29', 'releaseDate': '2016-02-29'}, {'resetDate': '2016-09-29', 'releaseDate': '2016-08-08'}, {'resetDate': '2016-11-25', 'releaseDate': '2016-10-03'}], 'estimatedResultsFirstSubmitDate': '2016-02-29'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D011318', 'term': 'Prilocaine'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-30', 'studyFirstSubmitDate': '2011-06-15', 'studyFirstSubmitQcDate': '2011-08-08', 'lastUpdatePostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain on a NRS-scale from 0 to 10', 'timeFrame': 'up to 14 days', 'description': 'Measuring postoperative pain in TCRE, TCRF or TCRP patients'}], 'secondaryOutcomes': [{'measure': 'PONV', 'timeFrame': 'postoperative and 2 weeks after discharge'}, {'measure': 'Time', 'timeFrame': '1 day', 'description': 'Operating time Recovery time Discharge time'}, {'measure': 'Medicin', 'timeFrame': '1 day', 'description': 'The type and quantity of painkillers and nausea medication. Remifentanil, propofol, citanest, efedrin og atropin.'}, {'measure': 'After discharge outcome measures', 'timeFrame': '2 weeks', 'description': 'Previous anestetics, pain, PONV, fever, bleeding, discharge time.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Transcervical Resection of Endometrium', 'Transcervical Resection of Fibroids', 'Transcervical Resection of Polyp']}, 'descriptionModule': {'briefSummary': 'The primary endpoint is to investigate the difference in pain between patients who receive deep sedation with spontaneous breathing versus patients who receive general anesthesia.', 'detailedDescription': 'Investigate the difference between two types of anesthesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years\n* females\n* are having a TCRE, TCRF or TCRP\n* speak and understand Danish\n* no mental problems\n\nExclusion Criteria:\n\n* \\<18 years old\n* don´t speak or understand Danish\n* mental problems\n* Lung problems\n* BMI \\>40\n* Big fibroma: \\>3x3 cm\n* abuser\n* Allergy towards i Propofol, Remifentanil and/or Citanest\n* pregnant'}, 'identificationModule': {'nctId': 'NCT01412632', 'briefTitle': 'Comparing Two Types of Sedation to Gynaecological Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Deep Sedation in Spontaneously Breathing Patients Combined With Local Anesthesia Versus General Anesthesia in Gynecological Patients at Same Day Surgical at Hospitalsenheden Horsens', 'orgStudyIdInfo': {'id': '2010-023843-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'General vs deep sedation', 'description': 'General anesthesia: remifentanil and propofol Deep sedation: remifentanil, propofol and citanest', 'interventionNames': ['Drug: Remifentanil, propofol and citanest']}], 'interventions': [{'name': 'Remifentanil, propofol and citanest', 'type': 'DRUG', 'description': 'iv remifentanil iv propofol im citanest', 'armGroupLabels': ['General vs deep sedation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8700', 'city': 'Horsens', 'state': 'Region Midt', 'country': 'Denmark', 'facility': 'Regionshospitalet Horsens', 'geoPoint': {'lat': 55.86066, 'lon': 9.85034}}], 'overallOfficials': [{'name': 'Igor Filipovski', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regionshospital Horsens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regionshospitalet Horsens', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-02-29', 'type': 'RELEASE'}, {'date': '2016-03-29', 'type': 'RESET'}, {'date': '2016-08-08', 'type': 'RELEASE'}, {'date': '2016-09-29', 'type': 'RESET'}, {'date': '2016-10-03', 'type': 'RELEASE'}, {'date': '2016-11-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Aarhus'}}}}