Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-30 @ 11:15 AM
Study NCT ID:
NCT04477733
Status:
COMPLETED
Last Update Posted:
2022-02-21
First Post:
2020-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059265', 'term': 'Visceral Pain'}], 'ancestors': [{'id': 'D059226', 'term': 'Nociceptive Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002077', 'term': 'Butorphanol'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-18', 'studyFirstSubmitDate': '2020-07-10', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visceral pain', 'timeFrame': '10 minutes after recovery', 'description': 'VAS score of visceral pain'}], 'secondaryOutcomes': [{'measure': 'visceral pain at 20 and 30 minutes after recovery', 'timeFrame': '20 and 30 minutes after recovery', 'description': 'VAS score of visceral pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Butorphanol, Visceral pain, Propofol, Gastroscopy, Colonoscopy'], 'conditions': ['Colonoscopy']}, 'referencesModule': {'references': [{'pmid': '36977981', 'type': 'DERIVED', 'citation': 'Wang J, Wang X, Liu H, Han R. Effect of butorphanol on visceral pain in patients undergoing gastrointestinal endoscopy: a randomized controlled trial. BMC Anesthesiol. 2023 Mar 28;23(1):93. doi: 10.1186/s12871-023-02053-9.'}]}, 'descriptionModule': {'briefSummary': 'The total incidence of abdominal pain after colonoscopy is almost 50%. Butorphanol is a mixed opioid receptor agonist-antagonist, which has strong sedative and analgesic effects. This clinical study aims to explore the effectiveness and safety of butorphanol combined with propofol for colonoscopy to reduce postoperative visceral pain, and provide a basis for improving the quality of surgery and comfortable medical treatment for patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA status I-11\n* patients performing colonoscopy\n* sign the informed consent\n\nExclusion Criteria:\n\n* BMI\\>30, pregnant\n* diabetes\n* depression\n* patients dependent on opioids\n* hypertension poorly controlled\n* serious complications of important organs\n* obvious abdominal pain before colonoscopy'}, 'identificationModule': {'nctId': 'NCT04477733', 'briefTitle': 'Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain', 'orgStudyIdInfo': {'id': 'wj20200710'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Butorphanol group', 'interventionNames': ['Drug: Butorphanol Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Butorphanol Injection', 'type': 'DRUG', 'description': "Inject 10 μg/kg of butorphanol, then propofol is injected until the patient's eyelash reflex disappears before performing colonoscopy", 'armGroupLabels': ['Butorphanol group']}, {'name': 'Saline', 'type': 'DRUG', 'description': "Inject saline and propofol until the patient's eyelash reflex disappears before performing colonoscopy", 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Ruquan Han', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}