Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05013320
Status:
WITHDRAWN
Last Update Posted:
2021-08-19
First Post:
2021-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Dexmedetomidine and Glycopyrrolate Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006024', 'term': 'Glycopyrrolate'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'We could not get the IRB approval', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2021-05-13', 'studyFirstSubmitQcDate': '2021-08-17', 'lastUpdatePostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of catheter-related bladder discomfort', 'timeFrame': '0 minute after entering the post-anesthetic care unit', 'description': 'No = not complaining of bladder discomfort on asking; Mild = report discomfot only on questioning; Moderate: report without questioning without behavior responses; Severe = report without questioniing accompanied by behavior responses. Mild, Moderate, Severe bladder discomfort is defined to have catheter-related bladder discomfort'}], 'secondaryOutcomes': [{'measure': 'Emergence agitation', 'timeFrame': '0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit', 'description': '(1)calm (2)slightly agitated but consolable (3)moderately agitated and inconsolable (4)severely agitated and highly inconsolable'}, {'measure': 'Delirium', 'timeFrame': '0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit', 'description': '(1)acute and fluctuating changes in mental status (2)inattention (3)disorganized or incoherent thinking (4)altered level of consciousness. (1),(2) and (3), (1),(2), and (4), or (1)(2)(3)and (4) are defined to have deilrium.'}, {'measure': 'Postoperative pain', 'timeFrame': '0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit', 'description': 'numerical rating scale (0=no pain to 10=worst pain imaginable)'}, {'measure': 'Sedation score', 'timeFrame': '0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit', 'description': '(1)anxious, agitated or restless (2)cooperative, oriented and trranquil (3)responds to commands, asleep (4)brisk response to light glabellar taps or oud noise (5)sluggish response to light glabellar taps or loud noise (6)noresponse'}, {'measure': 'Dry mouth', 'timeFrame': '0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit', 'description': 'yes or no'}, {'measure': 'postoperative nausea and vomiting', 'timeFrame': '0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit', 'description': 'yes or no'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Irritable']}, 'descriptionModule': {'briefSummary': 'Catheter-related bladder discomfort after transurethral resection of bladder tumor is frequent because of indwelling urinary catheter for irrigation. The mechanism of the catheter-related bladder discomfort is similar to that of overactive bladder, in which muscarinic acetylcholine receptors are stimulated. The catheter-related bladder discomfort is a well known predisposing factor for emergence delirium after general anesthesia. In this study, we aimed to compare the incidence of catheter-related bladder discomfort between dexmedetomidine only therapy and combind dexmedetomidine and glycopyrrolate therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical status I and II\n* elective transurethral resection of bladder tumor under general anesthesia\n\nExclusion Criteria:\n\n* arrhythmia\n* bladder outflow obstruction\n* overacitve bladder\n* end stage renal disease\n* neurogenic bladder\n* morbid obesity\n* psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT05013320', 'briefTitle': 'Combined Dexmedetomidine and Glycopyrrolate Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Kangbuk Samsung Hospital'}, 'officialTitle': 'Combined Dexmedetomidine and Glycopyrrolate Therapy for Prevention of Catheter Related Bladder Discomfort After Transurethral Bladder Surgery', 'orgStudyIdInfo': {'id': 'DEXLYCO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine only', 'description': 'dexmedetomidine is administered during the surgery', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'Combined dexmedetomidine and glycopyrrolate', 'description': 'glycopyrrolate and dexmedetomidine are administered during the surgery', 'interventionNames': ['Drug: Glycopyrrolate + dexmedetomidine']}], 'interventions': [{'name': 'Glycopyrrolate + dexmedetomidine', 'type': 'DRUG', 'description': 'Intravenous glycopyrrolate before anesthetic induction. Dexmedetomidine administration during the surgery.', 'armGroupLabels': ['Combined dexmedetomidine and glycopyrrolate']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine administration during the surgery.', 'armGroupLabels': ['Dexmedetomidine only']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kangbuk Samsung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Eunah Cho, MD', 'investigatorAffiliation': 'Kangbuk Samsung Hospital'}}}}