Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-30 @ 12:20 AM
Study NCT ID:
NCT01567657
Status:
COMPLETED
Last Update Posted:
2013-01-28
First Post:
2012-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D015742', 'term': 'Propofol'}], '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'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-25', 'studyFirstSubmitDate': '2012-01-04', 'studyFirstSubmitQcDate': '2012-03-29', 'lastUpdatePostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with a blood pressure drop of more than 30 mmHg and below 100 mmHg systolic', 'timeFrame': 'During examination (TEE), expected to be ca. 30 minutes'}], 'secondaryOutcomes': [{'measure': 'Number of patients with adverse events', 'timeFrame': 'At time of transfer to the ward, expected to be after ca. 1 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sedation in TEE', 'Blood pressure drop during TEE', 'Safety of sedation in TEE'], 'conditions': ['Hypotension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether sedation with a combination of pethidin hydrochlorid plus midazolam intravenously (i.v.) is superior to propofol i.v. alone in relation to blood pressure drops during an transesophageal echocardiographic examination (TEE).', 'detailedDescription': 'Randomisation is done immediately after information of the patient and obtaining of the informed consent. The average time for a TEE study is about 30 minutes. Data collection occurs during this time frame. ECG monitoring and data collection (blood pressure, heart rate, SO2) for the study protocol starts 6 minutes before the application of the sedation. At -6, -4, -2 minutes before the application of the sedation, baseline data are collected. The average systolic blood pressure of these three measures is taken as the reference blood pressure. This is the reference value to calculate the blood pressure drop during the examination. Blood pressure, pulse oxymetry, heart rate are taken every 2 minutes until the examination (TEE) is finished. The questionnaire (for second end points) is filled out by the patient within two hours after the examination. The patient will be followed for the duration of about one hour after the examination, if he is from the outpatient clinic. Patients from the hospital (inpatients) will be followed routinely in the clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients scheduled for TEE in our department who have signed the informed consent except those younger than 18 years and patients with a second or third etc. TEE\n\nExclusion Criteria:\n\n* \\< 18 years\n* intensive care patients\n* emergency department patients\n* breast feeding women\n* pregnant women\n* patients with an allergy to Propofol or its ingredient soy oil, Pethidin or Midazolam'}, 'identificationModule': {'nctId': 'NCT01567657', 'briefTitle': 'Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Münsterlingen'}, 'officialTitle': 'Phase II Study of Comparison of Two Sedation Regimen for Transesophageal Echocardiography in Point of View of Blood Pressure Response, Safety and Patient Comfort', 'orgStudyIdInfo': {'id': 'TEE 2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pethidin plus midazolam', 'description': 'Initial dose of 25 mg Pethidin iv. plus 1-2 mg Midazolam iv. Additional Bolus of Midazolam (1 mg wise iv.) if needed, until a maximal dose of 7 mg Midazolam iv.', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': 'Initial dose of Propofol of 50-60 mg iv. for patients 50 years or younger. Initial dose of Propofol of 30-40 mg iv. for patients over 50 years. If needed additional Bolus of 20-30 mg Propofol iv. as usual until sedation is achieved.', 'interventionNames': ['Drug: pethidin hydrochlorid, midazolam']}], 'interventions': [{'name': 'pethidin hydrochlorid, midazolam', 'type': 'DRUG', 'otherNames': ['Pethidin hydrochlorid = Meperidine (USA)', 'Midazolam = Dormicum'], 'description': 'Pethidin hydrochlorid: 25 mg iv. at the beginning of the examination Midazolam: 1-2 mg iv. at the beginning of the examination. Repetitive given in a dosis of 1 mg iv. until a total amount of 7 mg iv.', 'armGroupLabels': ['Propofol']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Propofol = Propofolum = Diprivan = Disoprivan'], 'description': '50 years and over: initial dose of 50-60 mg Propofol iv. Followed by bolus of 20-30 mg iv. until sedation is achieved.\n\n\\< 50 years: initial dose 30-40 mg Propofol iv. Followed by bolus of 10-20 mg until sedation is achieved.', 'armGroupLabels': ['Pethidin plus midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8596', 'city': 'Münsterlingen', 'state': 'Thurgau', 'country': 'Switzerland', 'facility': 'Kantonsspital Münsterlingen', 'geoPoint': {'lat': 47.63197, 'lon': 9.23271}}], 'overallOfficials': [{'name': 'Fritz Widmer, Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Departement of Cardiology, Kantonsspital Münsterlingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Münsterlingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}