[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567013":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":27,"responsibleParty":52,"collaborators":10,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":68,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":10,"overallStatus":74,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"China International Neuroscience Institution","OTHER",[8,12,15,18,21,24],{"label":9,"type":10,"description":11,"interventionNames":10},"1μg\u002F kg group",null,"Administration method of sufentanil: the dose of the first patient is 1μg \u002F kg, and the ratio between adjacent doses is 1.2. ( IOC2 values of \\\u003C 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":13,"type":10,"description":14,"interventionNames":10},"0.83μg\u002F kg group","Administration method of sufentanil: the dose of the first patient is 1μg \u002F kg, and the ratio between adjacent doses is 1.2. 1\u002F1.2=0.833 ( IOC2 values of \\\u003C 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":16,"type":10,"description":17,"interventionNames":10},"0.69μg\u002F kg group","Administration method of sufentanil: the dose of the first patient is 1μg \u002F kg, and the ratio between adjacent doses is 1.2. 0.833\u002F1.2=0.694( IOC2 values of \\\u003C 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":19,"type":10,"description":20,"interventionNames":10},"0.58μg\u002F kg group","Administration method of sufentanil: the dose of the first patient is 1μg \u002F kg, and the ratio between adjacent doses is 1.2. 0.694\u002F1.2=0.578( IOC2 values of \\\u003C 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":22,"type":10,"description":23,"interventionNames":10},"0.48μg\u002F kg group","Administration method of sufentanil: the dose of the first patient is 1μg \u002F kg, and the ratio between adjacent doses is 1.2. 0.578\u002F1.2=0.482( IOC2 values of \\\u003C 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":25,"type":10,"description":26,"interventionNames":10},"0.4μg\u002F kg group","Administration method of sufentanil: the dose of the first patient is 1μg \u002F kg, and the ratio between adjacent doses is 1.2. 0.482\u002F1.2=0.402( IOC2 values of \\\u003C 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.)",[28],{"facility":29,"status":10,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Xuanwu hospital","Beijing","Beijing Municipality","100053","China","CN",{"type":36,"coordinates":37},"Point",[38,39],116.39723,39.9075,{"lat":39,"lon":38},[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Yanghai Cui, PHD","CONTACT","83199270","15010283592","1055885750@qq.com",{"name":49,"role":44,"phone":50,"phoneExt":50,"email":51},"Tianlong Wang, Doctor","15910851623","w_tl5595@yeah.net",{"type":53,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100567013","ed50-of-sufentanil-for-intraoperative-analgesia-100567013",false,"NCT06662656","ED50 of Sufentanil for Intraoperative Analgesia","ED50 of Sufentanil with Dexmedetomidine Analgesia During Laparoscopic Cholecystectomy","ED50","Inclusion Criteria:\n\n1. ASA I \\~ II level;\n2. BMI22-30kg\u002Fm2;\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\\\u003C 85 mmHg or HR\\\u003C 45次\u002Fmin;\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.","ALL","18 Years","65 Years",{"count":66,"type":67},26,"ESTIMATED","1 Day","OBSERVATIONAL","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\".",[72,73],"Laparoscopic Cholecystectomy","Analgesics，Opioid","NOT_YET_RECRUITING","2024-10-27",{"date":77,"type":78},"2024-10-29","ACTUAL",{"date":80,"type":67},"2024-11-01",{"date":82,"type":67},"2025-01-30",{"name":5,"class":6},1]