Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-27 @ 8:46 PM
Study NCT ID:
NCT05331651
Status:
COMPLETED
Last Update Posted:
2024-08-16
First Post:
2022-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Glycopyrronium in Combination With Tropisetron in Anti-postoperative Nausea and Vomiting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006024', 'term': 'Glycopyrrolate'}, {'id': 'D000077526', 'term': 'Tropisetron'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 480}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2022-04-11', 'studyFirstSubmitQcDate': '2022-04-11', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Postoperative pain intensity', 'timeFrame': 'from the ending of surgery to 24 hours after surgery', 'description': 'Pain intensity is assessed by numerical rating scale (0-10, 0 represents painless; 10 represents intolerable pain)'}, {'measure': 'Postoperative analgesic requirements', 'timeFrame': 'from the ending of surgery to 24 hours after surgery', 'description': 'Analgesic requirements is assessed by recording the volume of patient controlled analgesia pump'}, {'measure': 'degree of satisfaction', 'timeFrame': 'from the ending of surgery to 24 hours after surgery', 'description': 'degree of satisfaction is assessed by patient using numerical rating scale (0-10, 0 represents unsatisfactory; 10 represents complete satisfaction)'}, {'measure': 'adverse reaction related to glycopyrronium and ondansetron', 'timeFrame': 'from the ending of surgery to 24 hours after surgery', 'description': 'adverse reaction is recorded according to follow-up visits after surgery'}], 'primaryOutcomes': [{'measure': 'incidence of postoperative nausea and vomiting', 'timeFrame': 'from the ending of surgery to 24 hours after surgery', 'description': 'postoperative nausea and vomiting is recorded according to follow-up visits after surgery'}], 'secondaryOutcomes': [{'measure': 'intensity of postoperative nausea', 'timeFrame': 'from the ending of surgery to 24 hours after surgery', 'description': 'intensity of postoperative nausea is assessed using Numeric Rating Scale (0-10, 0 represents no uncomfortable felling, 10 represents tolerableness)'}, {'measure': 'incidence of postoperative vomiting', 'timeFrame': 'from the ending of surgery to 24 hours after surgery', 'description': 'postoperative vomiting is recorded according to follow-up visits after surgery'}, {'measure': 'incidence of intervention requirement for nausea and vomiting', 'timeFrame': 'from the ending of surgery to 24 hours after surgery', 'description': 'this event is recorded according to follow-up visits after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '40859968', 'type': 'DERIVED', 'citation': 'Chen J, Piao G, Luan G, Yu Y, Zheng W, Li Y, Zhang C, Duan Y, Zhao M, Zhang Y, Xiang W, Cheng L, Ji C, Duan G, Huang H. Effects of Glycopyrronium Bromide as an Adjuvant Treatment in the Prevention of Nausea and Vomiting After Abdominal, Thyroid, and Breast Surgery: A Multicenter Randomized Controlled Trial. Drug Des Devel Ther. 2025 Aug 19;19:7123-7134. doi: 10.2147/DDDT.S515670. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'To compare the anti-nausea and vomiting effect between glycopyrronium in combination with tropisetron and normal saline in combination with tropisetron for patients receiving elective surgery under general anesthesia. Based on this study the investigators intend to explore the feasibility of using glycopyrronium as adjuvant drug to prevent postoperative nausea and vomiting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-cardiac surgery\n* American Society of Anesthesiologists classification I-III\n* Receive general anesthesia\n* Voluntarily receive postoperative intravenous controlled analgesia\n\nExclusion Criteria:\n\n* Puerpera or lactation women\n* Allergy or existing contraindication to glycopyrronium and tropisetron\n* Participate in other clinical drug trials within three months\n* Can not follow with the study procedure'}, 'identificationModule': {'nctId': 'NCT05331651', 'briefTitle': 'Effect of Glycopyrronium in Combination With Tropisetron in Anti-postoperative Nausea and Vomiting', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Effect of Glycopyrronium in Combination With Tropisetron in Anti-postoperative Nausea and Vomiting', 'orgStudyIdInfo': {'id': 'Glycopyrronium in anti-PONV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glycopyrronium in Combination With Tropisetron', 'interventionNames': ['Drug: Glycopyrronium in Combination With Tropisetron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline in Combination With Tropisetron', 'interventionNames': ['Drug: Normal Saline in Combination With Tropisetron']}], 'interventions': [{'name': 'Glycopyrronium in Combination With Tropisetron', 'type': 'DRUG', 'description': 'Glycopyrronium (0.2mg) in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.', 'armGroupLabels': ['Glycopyrronium in Combination With Tropisetron']}, {'name': 'Normal Saline in Combination With Tropisetron', 'type': 'DRUG', 'description': 'Normal Saline in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.', 'armGroupLabels': ['Normal Saline in Combination With Tropisetron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400010', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'He Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Affiliated Hospital, Chongqing Medical University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Within five years', 'ipdSharing': 'YES', 'description': 'The individual participant data for this study is available from the sponsor on reasonable request through email.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chongqing General Hospital', 'class': 'OTHER'}, {'name': 'Chongqing Medical University', 'class': 'OTHER'}, {'name': "The People's Hospital of DAZU ，Chongqing", 'class': 'UNKNOWN'}, {'name': "The People's Hospital of Chongqing Kaizhou District", 'class': 'UNKNOWN'}, {'name': 'Fuling Hospital affiliated to Chongqing University', 'class': 'UNKNOWN'}, {'name': 'Qianjiang Central Hospital of Chongqing', 'class': 'UNKNOWN'}, {'name': 'Stomatological Hospital of Chongqing Medical University', 'class': 'UNKNOWN'}, {'name': "People's Hospital of Changshou Chongqing", 'class': 'UNKNOWN'}, {'name': "The Ninth People's Hospital of Chongqing", 'class': 'UNKNOWN'}, {'name': "The First People's Hospital Of Chongqing Liang Jiang New Area", 'class': 'UNKNOWN'}, {'name': "People's Hospital of Xiushan County", 'class': 'UNKNOWN'}, {'name': "Wushan County People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Three Gorges Hospital of Chongqing University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, {'name': 'Department of Anesthesiology, Daping Hospital, Institute of Surgery Research, the Army Medical University', 'class': 'UNKNOWN'}, {'name': "The People's Hospital of Nanchuan", 'class': 'UNKNOWN'}, {'name': 'Chongqing Traditional Chinese Medicine Hospital', 'class': 'OTHER'}, {'name': "People's Hospital of Shapingba District， Chongqing", 'class': 'UNKNOWN'}, {'name': "Chongqing Liangping District People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Chongqing Jiangbei Hospital of Traditional Chinese Medicine', 'class': 'UNKNOWN'}, {'name': "People's Hospital of Chongqing Hechuan", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}