Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-03-11 @ 11:06 PM
Study NCT ID:
NCT03199105
Status:
UNKNOWN
Last Update Posted:
2018-08-17
First Post:
2017-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Education With Image Illustrations Enhances Effect of Tetracaine Mucilage in Alleviating Postoperative CRBD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-15', 'studyFirstSubmitDate': '2017-06-22', 'studyFirstSubmitQcDate': '2017-06-22', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of postoperative CRBD', 'timeFrame': '6 hours', 'description': 'The incidence of postoperative CRBD; CRBD was assessed according to the following scaling system: no CRBD; mild CRBD (complaint about CRBD on questioning only); moderate CRBD (complaint about CRBD without enquiring); and severe CRBD (complaint about CRBD without enquiring, with urinary urgency demonstrated by a spontaneous behavioural response such as flailing limb, verbal responses, or attempt to remove the catheter)'}], 'secondaryOutcomes': [{'measure': 'The severity of postoperative CRBD', 'timeFrame': '6 hours', 'description': 'The severity of CRBD was assessed according to the following scaling system: no CRBD; mild CRBD (complaint about CRBD on questioning only); moderate CRBD (complaint about CRBD without enquiring); and severe CRBD (complaint about CRBD without enquiring, with urinary urgency demonstrated by a spontaneous behavioural response such as flailing limb, verbal responses, or attempt to remove the catheter)'}, {'measure': 'The incidence of emergence agitation', 'timeFrame': '6 hours', 'description': 'Using Riker Sedation-Agitation Scale, where 5 to 7 represents agitation and 1 to 3 represents deep sedation'}, {'measure': 'The incidence of postoperative pain', 'timeFrame': '6 hours', 'description': 'The incidence of postoperative pain;Using a visual analog scale (VAS) score of 0-10, where 0 represents no pain and 10 represents worst imaginable pain.'}, {'measure': 'The severity of postoperative pain', 'timeFrame': '6 hours', 'description': 'Using a visual analog scale (VAS) score of 0-10, where 0 represents no pain and 10 represents worst imaginable pain.'}, {'measure': 'Incidenc of adverse events', 'timeFrame': '6 hours', 'description': 'Incidenc of adverse events, such asrespiratory depression (SpO2\\<90%), deep sedation, and toxicity of tetracaine'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Catheter Site Discomfort']}, 'referencesModule': {'references': [{'pmid': '30579342', 'type': 'DERIVED', 'citation': 'Zhou L, Zhou L, Tian L, Zhu D, Chen Z, Zheng C, Zhou T, Zeng X, Jiang X, Jiang C, Bo L. Preoperative education with image illustrations enhances the effect of tetracaine mucilage in alleviating postoperative catheter-related bladder discomfort: a prospective, randomized, controlled study. BMC Anesthesiol. 2018 Dec 22;18(1):204. doi: 10.1186/s12871-018-0653-y.'}]}, 'descriptionModule': {'briefSummary': 'Catheter-related bladder discomfort (CRBD) is not uncommon in male patients under general anesthesia, and it may cause patient agitation and exacerbated postoperative pain. In this study, the investigators will enroll male patients undergoing elective colonal and rectal surgery with surgical duration of at least 2 h, requiring catheterization of the urinary bladder with urinary catheterization after anesthetic induction, and compare preoperative education with image illustrations combined with local tetracaine mucilage vs. local tetracaine mucilage alone in alleviating CRBD during the post-operative period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18 years to 75 years.\n2. American Society of Anesthesiologists (ASA) physical status I, II.\n3. Undergoing elective noncardiac surgery with urinary catheterization after 4.anesthetic induction under general anesthesia.\n\n5.Duration of surgery more than 2h 6.Glasgow Coma Scale (GCS) score of 15. Ability to communicate.\n\nExclusion Criteria:\n\n1. History of bladder dysfunction, such as over active bladder (OAB, urinary frequency: more than three times in the night or more than eight times in 24 h).\n2. History of bladder outflow obstruction.\n3. Neurogenic bladder.\n4. Impaired renal function.\n5. Coagulopathy.\n6. Known allergies to any anesthetic agent.\n7. Family history of malignant hyperthermia.\n8. Impairment of communication or cognition.\n9. Psychopathy.\n10. Active participation in another trial where the primary endpoint follow-up is ongoing.\n11. Unwillingness or inability to comply with protocol procedures.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT03199105', 'briefTitle': 'Preoperative Education With Image Illustrations Enhances Effect of Tetracaine Mucilage in Alleviating Postoperative CRBD', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Preoperative Education With Image Illustrations Enhances the Effect of Tetracaine Mucilage in Alleviating Postoperative Catheter-related Bladder Discomfort: a Prospective, Randomized, Controlled Study', 'orgStudyIdInfo': {'id': '2014-159'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'preoperative education and tetracaine', 'interventionNames': ['Other: Preoperative education with image illustrations and/or local tetracaine mucilage']}, {'type': 'EXPERIMENTAL', 'label': 'tetracaine', 'interventionNames': ['Other: Preoperative education with image illustrations and/or local tetracaine mucilage']}], 'interventions': [{'name': 'Preoperative education with image illustrations and/or local tetracaine mucilage', 'type': 'OTHER', 'description': 'The patients were given preoperative education with image illustrations and/or local tetracaine mucilage to alleviate CRBD during the post-operative period.', 'armGroupLabels': ['preoperative education and tetracaine', 'tetracaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunling Jiang, Doctor', 'role': 'CONTACT', 'email': 'jiang_chunling@yahoo.com', 'phone': '18980601096'}], 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chunling Jiang', 'investigatorAffiliation': 'West China Hospital'}}}}