Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-02-20 @ 6:45 PM
Study NCT ID:
NCT04969068
Status:
UNKNOWN
Last Update Posted:
2022-01-10
First Post:
2021-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Median Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C522201', 'term': 'remimazolam'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-16', 'studyFirstSubmitDate': '2021-07-04', 'studyFirstSubmitQcDate': '2021-07-19', 'lastUpdatePostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of success duodenoscopy insertion', 'timeFrame': '1 day', 'description': 'success duodenoscopy insertion is defined by no body movement'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['remimazolam', 'alfentanil', 'duodenoscopy insertion', 'ERCP'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Remimazolam has shown promising results for sedation in colonoscopy . Alfentanil is widely used in the analgesia of ERCP . The purpose of the study was to determine the median effective dose of remimazolam for duodenoscopy insertion during ERCP with alfentanil 10µg/kg.', 'detailedDescription': "1. Title:The median effective dose of remimazolam for duodenoscopy insertion during ERCP with alfentanil 10µg/kg.\n2. Research center: Single center.\n3. The population of the study: Age is between 18 and 85 years; ASA I andIII levels; Patients undergone elective ERCP surgery, non-intubation patients;\n4. Sample size:The sample size was decided based on that of prior literature, which had demonstrated that at least six independent pairs with success/failure duodenoscopy insertion during ERCP are required for reliable estimates of the ED50 of remimazolam with the Dixon's up-and-down method, and data from seven independent pairs of patients were collected for this study. The ED50 (95% confidence interval, CI) of remimazolam for successful duodenoscopy insertion during ERCP was calculated according to the formula of Dixon and Massey.\n\n6\\. Interventions:The dose of remimazolam for each patient was determined by the response of the previously tested patients using the modified Dixon's up-and-down method.The first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size). Duodenoscopy insertion was conducted when MOAA/S≤1.The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement).' Movement was defined duodenoscopy insertion a failure was as gross purposeful muscular movement, coughing or vomiting occurring during or within 2 minutes of insertion of duodenoscopy. No movement was depicted when the reactions mentioned earlier were absent.If BIS\\>75 and MOAA/S \\> 1 when 3 min after the intravenous injection of remimazolam, it was considered a failure, and the patient received rescue sedation.."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age is between 18 and 85 years\n* ASA I and III, levels;\n* Patients undergone elective ERCP surgery, non-intubation patients;\n\nExclusion Criteria:\n\n* Chronic pain with long-term use of analgesics, psychotropic substances (including opioids, NSAIDs, sedatives, antidepressants), alcohol abusers, with known drug allergy;\n* BMI\\<18,BMI\\>30\n* Abnormal renal function (BUN or Cr ) ;\n* Previous abnormal surgical anesthesia recovery history;\n* Hypertension or systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg when the patient admission to the operating room\n* Suffering from esophageal reflux; • Sedatives, analgesics and antipruritic drugs were used 24 hours before operation;\n* Expected difficult intubation ;\n* Liver surgery history;\n* Opioids allergy history;\n* Take monoamine oxidase inhibitor or antidepressant within 15 days;\n* COPD;\n* Pregnant or parturient women;\n* Involved in other drug trials within three months;\n* Patients who can not communicate well with the researcher'}, 'identificationModule': {'nctId': 'NCT04969068', 'briefTitle': 'The Median Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Nankai Hospital'}, 'officialTitle': 'The Median Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg', 'orgStudyIdInfo': {'id': 'TianjinNK RM007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The median effective dose of remimazolam for duodenoscopy insertion with alfentanil 10µg/kg', 'description': "The first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size).The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement)'", 'interventionNames': ['Drug: Remimazolam']}], 'interventions': [{'name': 'Remimazolam', 'type': 'DRUG', 'description': "Interventions:The dose of remimazolam for each patient was determined by the response of the previously tested patients using the modified Dixon's up-and-down method.The first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size). Duodenoscopy insertion was conducted when MOAA/S≤1.The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement).' Movement was defined as duodenoscopy insertion a failure was as gross purposeful muscular movement, coughing or vomiting occurring during or within 2 minutes of insertion of duodenoscopy. No movement was depicted when the reactions mentioned earlier were absent. If BIS\\>75 and MOAA/S \\> 1 when 3 min after the intravenous injection of remimazolam, it was considered a failure, and the patient received rescue sedation.", 'armGroupLabels': ['The median effective dose of remimazolam for duodenoscopy insertion with alfentanil 10µg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300000', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Jianbo, Professor', 'role': 'CONTACT', 'email': 'yujianbo11@126.com', 'phone': '（022）27435008', 'phoneExt': '（022）27435027'}], 'facility': 'Tianjin Nankai Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Jianbo Yu, MD', 'role': 'CONTACT', 'email': 'yujianbo11@126.com', 'phone': '86-22-27435873'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Nankai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Jianbo Yu', 'investigatorAffiliation': 'Tianjin Nankai Hospital'}}}}