[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619659":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":27,"locations":27,"responsibleParty":36,"collaborators":27,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":27,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":67,"whyStopped":27,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":27},{"fullName":5,"class":6},"The First Affiliated Hospital of Xinxiang Medical College","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Remimazolam Besylate + Alfentanil","EXPERIMENTAL","Patients will receive total intravenous anesthesia induced and maintained with Remimazolam Besylate in combination with Alfentanil.",[13,14],"Drug: Propofol","Drug: Alfentanil Hydrochloride Injection",{"label":16,"type":17,"description":18,"interventionNames":19},"Propofol + Alfentanil","ACTIVE_COMPARATOR","Patients will receive total intravenous anesthesia induced and maintained with Propofol in combination with Alfentanil (standard care).",[20,14],"Drug: Remimazolam Besylate for Injection",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Remimazolam Besylate for Injection","A novel ultra-short-acting benzodiazepine. Induction dose: 0.3 mg\u002Fkg. Maintenance: continuous infusion at 0.2-1 mg\u002Fkg\u002Fh, titrated to maintain a BIS value between 40-60.",[16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Propofol","Standard intravenous anesthetic. Induction dose: 1.5-2 mg\u002Fkg. Maintenance: continuous infusion at 2-6 mg\u002Fkg\u002Fh, titrated to maintain a BIS value between 40-60.",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Alfentanil Hydrochloride Injection","A short-acting opioid analgesic. Administered at induction (10 μg\u002Fkg) and as a continuous infusion (0-1 μg\u002Fkg\u002Fmin) for intraoperative analgesia.",[16,9],{"type":37,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100619659","phase-4-a-randomized-controlled-clinical-trial-comparing-remimazolam-besylate-combined-with-alfentanil-versus-propofol-combined-with-alfentanil-for-anesthesia-in-thoracic-surgery-100619659",false,"NCT07347496","A Randomized, Controlled Clinical Trial Comparing Remimazolam Besylate Combined With Alfentanil Versus Propofol Combined With Alfentanil for Anesthesia in Thoracic Surgery","A Randomized, Single-blind, Parallel-controlled Clinical Study to Evaluate the Safety and Efficacy of Remimazolam Besylate Combined With Alfentanil in Anesthesia for Thoracic Surgery","RAA-TS","Inclusion Criteria:\n\n* Patients scheduled for elective thoracic surgery (e.g., pulmonary lobectomy, esophagectomy) under general anesthesia with preserved spontaneous respiration.\n* American Society of Anesthesiologists (ASA) physical status class I-III.\n* Age between 18 and 75 years.\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Severe hepatic or renal dysfunction (e.g., Child-Pugh class C, eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²).\n* Severe respiratory dysfunction (e.g., COPD GOLD stage 3-4, severe asthma).\n* Anticipated difficult airway (e.g., Mallampati class IV, history of difficult intubation).\n* Known allergy or hypersensitivity to benzodiazepines, opioids, or propofol.\n* Pregnancy or lactation.\n* Participation in another interventional clinical trial within the past 3 months.\n* Mental illness or inability to cooperate with assessments.","ALL","18 Years","75 Years",{"count":50,"type":51},50,"ESTIMATED","INTERVENTIONAL",[54],"PHASE4","Title: A Clinical Study Comparing Two Anesthesia Methods for Chest Surgery\n\nWhy is this study being done? Chest surgeries (like lung surgery) require safe and stable anesthesia. Currently, a drug called propofol combined with an opioid painkiller (alfentanil) is commonly used. However, propofol can sometimes cause low blood pressure and low oxygen levels. A newer drug called remimazolam may cause fewer of these side effects. This study aims to compare the safety and effectiveness of remimazolam (combined with alfentanil) versus propofol (combined with alfentanil) for anesthesia during chest surgery.\n\nWhat will happen in the study?\n\nPatients scheduled for elective chest surgery will be invited to participate. If they agree, they will be randomly assigned (like flipping a coin) to one of two groups:\n\n* Group 1: Will receive remimazolam and alfentanil for anesthesia.\n* Group 2: Will receive propofol and alfentanil for anesthesia (standard care).\n\nThe anesthesiologist will carefully monitor patients during and after surgery. We will mainly compare how often patients in each group experience two safety issues: low oxygen levels in the blood and low blood pressure. We will also record recovery times, drug doses, side effects, and ask patients and surgeons about their satisfaction.\n\nWho can participate? Adults aged 18-65 who are scheduled for elective chest surgery and are in relatively stable health (ASA physical status I-III).\n\nWhere is the study taking place? This study will be conducted in the Department of Anesthesiology at The First Affiliated Hospital of Xinxiang Medical College, Henan, China.\n\nEthics Approval:\n\nThis study has been reviewed and approved by the Ethics Committee of The First Affiliated Hospital of Xinxiang Medical College (Approval Number: (2025) Medical Ethics Committee Approval No. 29).",[57,58,59],"Thoracic Surgery","Anesthesia","Non-intubated Anesthesia",[61,62,29,63,64,65,66],"Remimazolam","Alfentanil","Non-intubated","Tubeless Anesthesia","Spontaneous Ventilation Spontaneous Ventilation","Total Intravenous Anesthesia Total Intravenous Anesthesia","NOT_YET_RECRUITING","2026-01-09",{"date":70,"type":71},"2026-01-16","ACTUAL",{"date":73,"type":51},"2026-03-01",{"date":75,"type":51},"2028-05-31",{"name":5,"class":6}]