[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557857":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":59,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DEX","PLACEBO_COMPARATOR","A loading dose of DEX 0.3 µg\u002Fkg was infused intravenously at a constant speed within 10 min after the patients entered the operating room, and the DEX maintenance dose was infused at 0.3µg\u002Fkg\u002Fh until the end of the first stage (deep-brain stimulation implantation) of the operation. After the craniotomy, normal saline is infused at a rate of 3 ml\u002Fkg\u002Fh until the completion of electrode implantation, prior to microelectrode recording (MER) and electrode insertion. Blood pressure and heart rate of the patient are closely monitored after drug administration to maintain circulatory stability.",[13],"Drug: normal Saline",{"label":15,"type":16,"description":17,"interventionNames":18},"DEX-KET","EXPERIMENTAL","A loading dose of DEX 0.3 µg\u002Fkg was infused intravenously at a constant speed within 10 min after the patients entered the operating room, and the DEX maintenance dose was infused at 0.3µg\u002Fkg\u002Fh until the end of the first stage (deep-brain stimulation implantation) of the operation. After the craniotomy, esketamine (0.1mg\u002Fml) is infused at a rate of 3ml\u002Fkg\u002Fh until the completion of electrode implantation, prior to microelectrode recording (MER) and electrode insertion. Blood pressure and heart rate of the patient are closely monitored after drug administration to maintain circulatory stability.",[19],"Drug: esketamine",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","esketamine","After the craniotomy, a continuous infusion of ketamine at a rate of 0.3 mg\u002Fkg\u002Fh (0.3 ml\u002Fkg\u002Fh) is administered until the completion of electrode implantation, prior to microelectrode recording (MER) and electrode insertion. After the administration of the drug, close monitoring of the patient's blood pressure and heart rate is conducted to maintain circulatory stability.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"normal Saline","After the craniotomy, a continuous infusion of normal saline at a rate of 0.3 ml\u002Fkg\u002Fh is administered until the completion of electrode implantation, prior to microelectrode recording (MER) and electrode insertion. After the administration of the drug, close monitoring of the patient's blood pressure and heart rate is conducted to maintain circulatory stability.",[9],[32],{"name":33,"affiliation":34,"role":35},"Ruquan Han, MD,PhD","Study Principal Investigator","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","8610-59976660","ruquan.han@gmail.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Beijing Tiantan Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100070","China","CN",{"type":51,"coordinates":52},"Point",[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57,58],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":35,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Ruquan Han","Director of Anesthesiology Department","100557857","esketamine-in-microelectrode-recording-guided-subthalamic-deep-brain-stimulation-for-parkinsons-disease-100557857",false,"NCT06543563","Esketamine in Microelectrode Recording-guided Subthalamic Deep-Brain Stimulation for Parkinson's Disease","Esketamine in Microelectrode Recording-guided Subthalamic Deep-Brain Stimulation for Parkinson's Disease（ASPIRE）：A Randomized Controlled, Double-blind Study","ASPIRE","Inclusion Criteria:\n\n1.50-80 years old, ASA grade II-III; 2.Bilateral STN-DBS of patients with Parkinson's disease; 3.Signed informed consent.\n\nExclusion Criteria:\n\n1. Obstructive sleep apnea;\n2. BMI \\> 30kg\u002Fm2;\n3. Estimated difficult airway;\n4. Severe preoperative anxiety;\n5. Serious dysfunction of important organs (i.e. heart failure, renal or liver dysfunction)\n6. A history of allergy to the anaesthetics.","ALL","50 Years","80 Years",{"count":74,"type":75},102,"ESTIMATED","INTERVENTIONAL",[78],"NA","Under regional anesthesia, subthalamic nucleus deep brain stimulation (STN-DBS) has proven to be an effective therapeutic approach for improving motor symptoms in Parkinson's disease. However, a significant portion of Parkinson's disease (PD) patients is unable to cooperate with the surgery, necessitating the use of awake sedation. Nevertheless, the administration of anesthetic drugs often impacts the electrical signals recorded by microelectrodes to varying degrees. This study is designed as a prospective, randomized, placebo-controlled, double-blind, two-arm investigation. PD patients scheduled for bilateral STN-DBS surgery will be randomly assigned to either the Dexmedetomidine group or the Dexmedetomidine combined with Esketamine group. The differences in neural activity between the two groups will be assessed using the normalized root mean square (NRMS) method. The primary outcome measure is NRMS, while secondary outcome measures include differences in beta oscillation power spectrum analysis, postoperative delirium incidence, postoperative changes in sleep disturbances, postoperative depression, anxiety status, and occurrence of adverse events.",[81,82,83],"PD - Parkinson's Disease","Deep Brain Stimulation","Esketamine","2024-08-04",{"date":86,"type":87},"2024-08-09","ACTUAL",{"date":86,"type":75},{"date":90,"type":75},"2026-01-31",{"name":5,"class":6},1]