Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-01 @ 9:14 PM
Study NCT ID:
NCT06662656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-29
First Post:
2024-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ED50 of Sufentanil for Intraoperative Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-27', 'studyFirstSubmitDate': '2024-03-17', 'studyFirstSubmitQcDate': '2024-10-27', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of the IOC2 target a reachment', 'timeFrame': 'through study completion, an average of 1 day', 'description': 'The primary endpoint of the study was the attainment rate of the IOC2 target during operation'}], 'secondaryOutcomes': [{'measure': 'visual analog scale score', 'timeFrame': '12 hours and 24hours after surgery', 'description': 'visual analog scale (VAS) score at 12 h and 24 hours after operation,'}, {'measure': 'The ratio of vomiting', 'timeFrame': '0 day, 1 day, 2 day after operation', 'description': 'the ratio of vomiting'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '0 day', 'description': 'Systolic Blood Pressure reflect haemodynamics changeduring operation'}, {'measure': 'Dystolic Blood Pressure', 'timeFrame': '0 day', 'description': 'Dystolic Blood Pressure during operation'}, {'measure': 'Mean Blood Pressure', 'timeFrame': '0 day', 'description': 'Mean Blood Pressure during opeation'}, {'measure': 'Heart rate', 'timeFrame': '0 day', 'description': 'Heart rate during operation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laparoscopic Cholecystectomy', 'Analgesics，Opioid']}, 'descriptionModule': {'briefSummary': '1. Sufentanil as an strong analgesic is used widespreadly during laparoscopic cholecystectomy.\n2. Lower dosages of sufentanil facilitated with dexmedetomidine can offer enough analgesia effect.\n3. The investigator are planning use the most classical method for determining the ED50 or half effective concentration of sufentanil facilitated with dexmedetomidine using sequential method, which is also called" up and down method" and" ladder method".', 'detailedDescription': 'The concordance of the current research is that lower dosages of sufentanil facilitated with dexmedetomidine can offer enough analgesia effect through operation. However, the dosages of sufentanil used in various researches vary greatly of operations. Previous studies have shown that the amount of sufentanil required for intraoperative analgesia is smaller than that required while dexmedetomindine facilitated. Although the appropriate dosage of sufentanil required for operation can ensure the analgesic effect of operation, excessive dosage can cause severe choking during intubation, postoperative nausea and vomiting, hyperalgesia, and chronic postoperative pain. The investigator planning use the most classical method for determining the ED50 or half effective concentration of sufentainl combined with dexmedetomidine using sequential method, which is also called " up and down method" and " ladder method".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients in Xuanwu Hospital for elective laparoscopic cholecystectomy are selected. Before surgery, visitors recorded basic information such as the patient's sex, age, BMI, ASA grade in the ward.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ASA I \\~ II level;\n2. BMI22-30kg/m2;\n3. Those who intend to undergo laparoscopic cholecystectomy;\n4. Age 18\\~65 years.\n\nExclusion Criteria:\n\n1. Has been allergic to the drugs used in this study;\n2. Patients with a history of chronic use of alcohol, smoke or other sedative drugs;\n3. Patients took opioids and other analgesics before surgery;\n4. Emergency operation;\n5. Stress, anxiety resulting in secretion of catecholamine;\n6. Patients with neuropsychiatric disorders, coma, depression, cognitive impairment and Alzheimer's disease;\n7. Patients with epilepsy, autonomic nervous dysfunction and other diseases with abnormal EEG results;\n8. SBP\\< 85 mmHg or HR\\< 45次/min;\n9. Has implanted pacemaker;\n10. Patients were unwilling or disable to finish whole study;\n11. Patients with acute upper respiratory infections, liver or kidney failure and severe cardiopulmonary dysfunction."}, 'identificationModule': {'nctId': 'NCT06662656', 'acronym': 'ED50', 'briefTitle': 'ED50 of Sufentanil for Intraoperative Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'China International Neuroscience Institution'}, 'officialTitle': 'ED50 of Sufentanil with Dexmedetomidine Analgesia During Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'CINI-AD-202403-13'}, 'secondaryIdInfos': [{'id': 'CINI-AD-202403-13', 'type': 'OTHER', 'domain': 'XuanWu Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1μg/ kg group', 'description': 'Administration method of sufentanil: the dose of the first patient is 1μg / kg, and the ratio between adjacent doses is 1.2. ( IOC2 values of \\< 60, which were the target of this study, indicate adequate analgesic efect and analgesic level for regional surgery. IOC2 values of ≥ 60 indicate inadequate use of analgesics. If the analgesic effect of this patient is satisfactory, the next patient will use the lower dose. If the analgesic efect of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)'}, {'label': '0.83μg/ kg group', 'description': 'Administration method of sufentanil: the dose of the first patient is 1μg / kg, and the ratio between adjacent doses is 1.2. 1/1.2=0.833 ( IOC2 values of \\< 60, which were the target of this study, indicate adequate analgesic efect and analgesic level for regional surgery. IOC2 values of ≥ 60 indicate inadequate use of analgesics. If the analgesic effect of this patient is satisfactory, the next patient will use the lower dose. If the analgesic efect of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)'}, {'label': '0.69μg/ kg group', 'description': 'Administration method of sufentanil: the dose of the first patient is 1μg / kg, and the ratio between adjacent doses is 1.2. 0.833/1.2=0.694( IOC2 values of \\< 60, which were the target of this study, indicate adequate analgesic efect and analgesic level for regional surgery. IOC2 values of ≥ 60 indicate inadequate use of analgesics. If the analgesic effect of this patient is satisfactory, the next patient will use the lower dose. If the analgesic efect of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)'}, {'label': '0.58μg/ kg group', 'description': 'Administration method of sufentanil: the dose of the first patient is 1μg / kg, and the ratio between adjacent doses is 1.2. 0.694/1.2=0.578( IOC2 values of \\< 60, which were the target of this study, indicate adequate analgesic efect and analgesic level for regional surgery. IOC2 values of ≥ 60 indicate inadequate use of analgesics. If the analgesic effect of this patient is satisfactory, the next patient will use the lower dose. If the analgesic efect of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)'}, {'label': '0.48μg/ kg group', 'description': 'Administration method of sufentanil: the dose of the first patient is 1μg / kg, and the ratio between adjacent doses is 1.2. 0.578/1.2=0.482( IOC2 values of \\< 60, which were the target of this study, indicate adequate analgesic efect and analgesic level for regional surgery. IOC2 values of ≥ 60 indicate inadequate use of analgesics. If the analgesic effect of this patient is satisfactory, the next patient will use the lower dose. If the analgesic efect of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)'}, {'label': '0.4μg/ kg group', 'description': 'Administration method of sufentanil: the dose of the first patient is 1μg / kg, and the ratio between adjacent doses is 1.2. 0.482/1.2=0.402( IOC2 values of \\< 60, which were the target of this study, indicate adequate analgesic efect and analgesic level for regional surgery. IOC2 values of ≥ 60 indicate inadequate use of analgesics. If the analgesic effect of this patient is satisfactory, the next patient will use the lower dose. If the analgesic efect of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Yanghai Cui, PHD', 'role': 'CONTACT', 'email': '1055885750@qq.com', 'phone': '83199270', 'phoneExt': '15010283592'}, {'name': 'Tianlong Wang, Doctor', 'role': 'CONTACT', 'email': 'w_tl5595@yeah.net', 'phone': '15910851623', 'phoneExt': '15910851623'}], 'facility': 'Xuanwu hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China International Neuroscience Institution', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}