Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-05 @ 6:06 PM
Study NCT ID:
NCT00563069
Status:
UNKNOWN
Last Update Posted:
2010-07-07
First Post:
2007-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Premedication With Oral Midazolam in Patients Undergoing Rigid Cystoscopy: A Randomized, Double-blind, Placebo-controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2006-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-07-06', 'studyFirstSubmitDate': '2007-11-21', 'studyFirstSubmitQcDate': '2007-11-23', 'lastUpdatePostDateStruct': {'date': '2010-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score during the procedure as assessed by visual analog scale'}], 'secondaryOutcomes': [{'measure': "Patient's satisfaction"}, {'measure': "Patient's willingness to repeat the procedure"}, {'measure': "Patient's cooperativeness during the procedure as assessed by surgeons"}]}, 'conditionsModule': {'keywords': ['diagnostic and therapeutic rigid cystoscopy'], 'conditions': ['Cystoscopy']}, 'descriptionModule': {'briefSummary': "To investigate the efficacy of oral midazolam for patients undergoing rigid cystoscopy in:\n\n1. relieving patient's anxiety and improving satisfaction\n2. reducing procedure-related pain\n3. facilitating the diagnostic and therapeutic interventions during rigid cystoscopy"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective rigid cystoscopy\n* Either diagnostic or therapeutic\n* Age between 18 to 80\n\nExclusion Criteria:\n\n* Patients with allergy to midazolam or other benzodiazepine groups\n* Pregnancy\n* Emergency rigid cystoscopy\n* ASA class 3 or above\n* Patients on psychiatric medications\n* Alcoholics'}, 'identificationModule': {'nctId': 'NCT00563069', 'briefTitle': 'Premedication With Oral Midazolam in Patients Undergoing Rigid Cystoscopy: A Randomized, Double-blind, Placebo-controlled Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Authority, Hong Kong'}, 'officialTitle': 'Premedication With Oral Midazolam in Patients Undergoing Rigid Cystoscopy: A Randomized, Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'CRE-2005.250-T'}, 'secondaryIdInfos': [{'id': 'HARECCTR0500009'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Midazolam', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wilfred LM Mui, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chi Fai Ng, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael CW Cheng, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shu Yin Chan, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Surgery, Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Shirley YW Liu, Dr', 'role': 'CONTACT', 'email': 'liu_yws@yahoo.com.hk', 'phone': '(852) 2632 2625'}], 'overallOfficials': [{'name': 'Shirley YW Liu, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, Prince of Wales Hospital/ The Chinese Univerisity of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Authority, Hong Kong', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}]}}}