Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 10:53 PM
Study NCT ID:
NCT04727034
Status:
UNKNOWN
Last Update Posted:
2022-10-12
First Post:
2021-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C573194', 'term': '4-methylbenzenesulfonic acid'}, {'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', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-07', 'studyFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2021-01-25', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The success rate of remazolam tosylate for sedation in gastroscopy diagnosis and treatment', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average of 2 hours', 'description': '1\\) Complete the entire process of gastroscopy; 2) No sedative remedy is given; 3) After the initial dose of the test drug is administered, additional administration ≤ 2 times within any 5-minute period; 4) The initial dose of propofol After the end, within any 5-minute period of additional administration ≤ 2 times, it is recorded as propofol (control group) successfully sedated'}], 'secondaryOutcomes': [{'measure': 'Sedation induction time', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average of 2 hours', 'description': 'induction time'}, {'measure': 'Sedation recovery time', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average of 2 hours', 'description': 'recovery time'}, {'measure': 'Incidence of drug injection pain', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average of 2 hours', 'description': 'drug injection pain'}, {'measure': 'Doctor satisfaction and patient satisfaction', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average of 2 hours', 'description': 'There is a scale from 1 to 10. Endoscopists and patients will score their satisfaction with the scale ,with 1-3 (dissatisfied),4-6 (satisfied) and 7-10 (very satisfied) after gastroscopy.'}, {'measure': 'The time it takes for the patient to wake up and leave the hospital if the Sedation/Anaesthesia Discharge Rating Scale score exceeds 9 points;', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average of 2 hours', 'description': 'Sedation/Anaesthesia Discharge Rating Scale'}, {'measure': 'The incidence of hypoxia during sedation', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average of 2 hours', 'description': '(75% ≤ SpO2 \\< 90% for \\<60 s)；(SpO2 \\< 75% for any duration or 75% \\< SpO2 \\< 90% for \\>/=60 s)'}, {'measure': 'Other adverse events assessed by the World SIVA adverse sedation event reporting tool', 'timeFrame': 'Patients will be followed for the duration of hospital stay, an expected average of 2 hours', 'description': 'other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypoxia', 'Efficacy and Safety', 'Gastroscope', 'Remimazolam', 'Propofol'], 'conditions': ['Hypoxia', 'Gastric Cancer', 'Sedation Complication', 'Propofol Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '36510290', 'type': 'DERIVED', 'citation': 'Zhu H, Su Z, Huai X, Chen C, Zhang X, Zhou J, Su D. Efficacy and safety of remimazolam tosylate for sedation during upper gastrointestinal endoscopy: study protocol for a multicenter randomized controlled trial. Trials. 2022 Dec 12;23(1):995. doi: 10.1186/s13063-022-06935-0.'}]}, 'descriptionModule': {'briefSummary': 'Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high. Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 1)18≤age≤60 years old, no gender limit; 2) Patients receiving routine gastroscopy diagnosis and treatment; 3) ASA score is I or II; 4) 18 kg/m2\\<BMI\\<28kg/m2； 5) It is estimated that the operation time of gastroscope will not exceed 30 minutes; 6) Clearly understand, voluntarily participate in the research, and be signed and informed consent.\n\nExclusion Criteria:\n\n1. Need to perform complicated endoscopic diagnosis and treatment techniques (such as cholangiopancreatography Surgery, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosa Stripping, oral endoscopic muscle dissection, etc.);\n2. Patients who intend to undergo tracheal intubation;\n3. It is judged to be difficult to manage the respiratory tract (modified Mallampati score is IV)patient;\n4. Anemia or thrombocytopenia,( Hb\\<90g/L, PLT\\<80×109/L);\n5. Diagnosed lung diseases (asthma, bronchitis, COPD, Pulmonary bullae,pulmonary embolism, pulmonary edema, lung cancer);\n6. Liver and kidney disease;( AST and/or ALT≥2.5×ULN,TBIL≥1.5×ULN, blood creatinine is greater than the upper limit of normal);\n7. There is a history of drug and/or alcohol abuse within 2 years before the beginning of the screening period.The average daily alcohol consumption exceeds 2 units of alcohol (1 unit = 360 mL beer Liquor or 45 mL liquor with 40% alcohol content or 150 mL grapes liqueur);\n8. Hypertensive patients whose blood pressure has not been satisfactorily controlled by antihypertensive drugs(Sitting systolic blood pressure ≥160 mmHg during screening period, and/or diastolic pressure during screening period Pressure ≥100 mmHg);\n9. Sitting systolic blood pressure ≤90 mmHg during the screening period;\n10. Women who are pregnant or breastfeeding;\n11. Benzodiazepines, opioids, propofol, lidoca Those who are allergic or contraindicated due to their drug components;\n12. Participated in other drug clinical trials as subjects in the past 3 months;\n13. The investigator believes that it is not appropriate to participate in this trial;\n14. A well-diagnosed heart disease (heart failure, angina pectoris, myocardial infarction, heart rhythmabnormalities etc.).'}, 'identificationModule': {'nctId': 'NCT04727034', 'briefTitle': 'Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'A Multicenter, Randomized, Single-blind, Parallel Controlled Clinical Study on the Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy', 'orgStudyIdInfo': {'id': 'sudiansan1215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Propofol（1.5mg/kg）', 'interventionNames': ['Drug: Propofol']}, {'type': 'EXPERIMENTAL', 'label': 'Test group 1（Remimazolam tosylate 0.15mg/kg）', 'description': 'Remimazolam tosylate 0.15mg/kg', 'interventionNames': ['Drug: Remimazolam tosylate']}, {'type': 'EXPERIMENTAL', 'label': 'Test group 2（Remimazolam tosylate 0.2mg/kg）', 'description': 'Remimazolam tosylate 0.2mg/kg', 'interventionNames': ['Drug: Remimazolam tosylate']}], 'interventions': [{'name': 'Remimazolam tosylate', 'type': 'DRUG', 'description': 'Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.', 'armGroupLabels': ['Test group 1（Remimazolam tosylate 0.15mg/kg）', 'Test group 2（Remimazolam tosylate 0.2mg/kg）']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai, China', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Diansan Su, Dr.', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+862168383702'}], 'facility': 'Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai, China', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangrui D Wang, Dr.', 'role': 'CONTACT', 'phone': '13701901953'}], 'facility': 'Shanghai East Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Jiaxing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming Yao, PhD', 'role': 'CONTACT', 'email': 'jxyaoming@163.com', 'phone': '13758394990'}], 'facility': 'Affiliated Hospital of Jiaxing University', 'geoPoint': {'lat': 30.7522, 'lon': 120.75}}, {'city': 'Jiaxing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongmei zhou', 'role': 'CONTACT', 'phone': '13867300139'}], 'facility': 'The Second Affifiliated Hospital of Jiaxing University', 'geoPoint': {'lat': 30.7522, 'lon': 120.75}}, {'city': 'Nanchang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'shibiao chen', 'role': 'CONTACT', 'email': 'chenlaoshi1111@163.com', 'phone': '13870892918'}], 'facility': 'The First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}], 'centralContacts': [{'name': 'Diansan Su, Dr.', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+862168383702'}, {'name': 'Huichen zhu, M.S.', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+862168383702'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai East Hospital', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Jiaxing University', 'class': 'OTHER'}, {'name': 'The Second Affifiliated Hospital of Jiaxing University', 'class': 'UNKNOWN'}, {'name': 'The First Affiliated Hospital of Nanchang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Chair of the Department of Anesthesiology', 'investigatorFullName': 'diansan su', 'investigatorAffiliation': 'RenJi Hospital'}}}}