Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
Study NCT ID:
NCT05801757
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2023-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003108', 'term': 'Colonic Diseases'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522201', 'term': 'remimazolam'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single blind, prospective, randomized controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2023-03-26', 'studyFirstSubmitQcDate': '2023-04-05', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sedation success rate', 'timeFrame': '1 day', 'description': 'Evaluating the success rate of sedation using the modified MOAA/S scoring table'}], 'secondaryOutcomes': [{'measure': 'Intraoperative time record', 'timeFrame': 'Intraoperative', 'description': 'Anesthesia time; Operation time; Wake up time; PACU time'}, {'measure': 'Drug usage', 'timeFrame': '1 day', 'description': 'doses of propofol,remimazolam and other drugs used'}, {'measure': 'The incidence of adverse reactions during surgery', 'timeFrame': '1 day', 'description': 'includes: body movements, hypoxemia, hypotension, bradycardia; Intraoperative awareness'}, {'measure': 'Incidence of postoperative adverse reactions', 'timeFrame': '24 hours after surgery', 'description': 'Postoperative nausea and vomiting, postoperative pain, hypotension, bradycardia, dizziness'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colonoscopic polypectomy', 'elderly patients'], 'conditions': ['Colon Disease']}, 'descriptionModule': {'briefSummary': 'To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy.', 'detailedDescription': 'To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy, and to screen the optimal dose of remidazolam, in order to provide a more reasonable and safe sedative and analgesic drug regimen for elderly outpatients undergoing colonoscopic polypectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 60-80 years old;\n* ASA Level I - III;\n* Operation time: 15min\\~1h;\n* BMI18.0-29.9；\n\nExclusion Criteria:\n\n* Emergency surgery;\n* Patients with high risk of gastric satiety and reflux aspiration;\n* Allergies to benzodiazepines and opioids;\n* Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours;\n* Abnormal liver and kidney function;\n* Previous drug use history;\n* Recently participated in other clinical studies;\n* Patients who cannot cooperate with communication.'}, 'identificationModule': {'nctId': 'NCT05801757', 'briefTitle': 'Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Sedative Effect of Remidazolam Besylate Continuous Pump Infusion for Colonoscopic Polypectomy in Elderly Patients', 'orgStudyIdInfo': {'id': 'CIRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol group', 'description': 'propofol 2-3mg/kg/h', 'interventionNames': ['Drug: Propofol']}, {'type': 'EXPERIMENTAL', 'label': 'R1 group', 'description': 'remimazolam 0.5mg/kg/h', 'interventionNames': ['Drug: Remimazolam']}, {'type': 'EXPERIMENTAL', 'label': 'R2 group', 'description': 'remimazolam 0.75mg/kg/h', 'interventionNames': ['Drug: Remimazolam']}], 'interventions': [{'name': 'Remimazolam', 'type': 'DRUG', 'otherNames': ['Remimazolam besylate'], 'description': 'Using two different doses of remidazolam for continuous pumping to maintain anesthetic effect', 'armGroupLabels': ['R1 group', 'R2 group']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Diprivan'], 'description': 'propofol 2-3mg/kg/h', 'armGroupLabels': ['Propofol group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'aihua Du, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'You can request it from the main researcher'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'aijun xu', 'investigatorAffiliation': 'Tongji Hospital'}}}}