[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649717":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":26,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":26,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":26,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":54,"whyStopped":26,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":26},{"fullName":5,"class":6},"General Hospital of Ningxia Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Remimazolam (Group R)","EXPERIMENTAL","Remimazolam was used for both anesthesia induction and maintenance",[13],"Drug: Remimazolam",{"label":15,"type":16,"description":17,"interventionNames":18},"Propofol (Group P)","ACTIVE_COMPARATOR","Propofol was used for both anesthesia induction and maintenance.",[19],"Drug: propofol",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Remimazolam","In the remimazolam group, anesthesia was induced with remimazolam 0.2 mg\u002Fkg, sufentanil 0.3-0.5 μg\u002Fkg, and rocuronium 0.6-0.8 mg\u002Fkg. After 3 minutes of preoxygenation, tracheal intubation was performed, and mechanical ventilation was initiated to maintain PETCO₂ at 30-40 mmHg. Anesthesia was maintained with continuous infusions of remimazolam and remifentanil, guided by anesthetic depth monitoring. Rocuronium was supplemented intermittently and discontinued 30 minutes before the end of surgery.Polysomnography (PSG) was performed both preoperatively and postoperatively to measure total sleep time and sleep architecture. Subjective sleep quality was assessed using validated questionnaires during postoperative follow-up.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"propofol","In the propofol group, anesthesia was induced with propofol 1.0-1.5 mg\u002Fkg, sufentanil 0.3-0.5 μg\u002Fkg, and rocuronium 0.6-0.8 mg\u002Fkg. Anesthesia was maintained with continuous infusions of propofol and remifentanil. All other procedural details were identical to those in the remimazolam group.",[15],{"type":32,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100649717","remimazolam-for-postoperative-sleep-in-elderly-patients-100649717",false,"NCT07740343","Remimazolam for Postoperative Sleep in Elderly Patients","Remimazolam and Postoperative Sleep in Elderly Patients Undergoing Laparoscopic Colorectal Cancer Resection: A Randomized, Double-Blind, PSG-Based Controlled Trial","Inclusion Criteria:\n\n* Aged between 65 and 80 years.\n* Scheduled for elective laparoscopic radical resection of colorectal cancer.\n* American Society of Anesthesiologists (ASA) physical status class II-III.\n* Able to understand the study protocol and provide written informed consent.\n\nExclusion Criteria:\n\n* Known allergy to any study medications.\n* Preoperative sleep disorder (Pittsburgh Sleep Quality Index \\[PSQI\\] score \\> 10).\n* Regular use of sedatives, antipsychotics or hormonal drugs within the past month.\n* Preoperative cognitive impairment, screened using the education-adjusted Mini-Mental State Examination (MMSE).\n* Preoperative history of neurological or psychiatric disorders, including Alzheimer's disease, Parkinson's disease, depression and anxiety disorders.\n* Severe preoperative comorbidities involving the cardiovascular, cerebrovascular, respiratory, hepatic or renal systems, as follows:New York Heart Association (NYHA) functional class IV; current or recent (within 2 months) congestive heart failure; myocardial infarction or coronary stent implantation within the preceding 3 months; Uncontrolled frequent ventricular premature beats (\\>5 beats per minute), couplets, triplets, paired ventricular arrhythmias, multifocal ventricular premature beats, or R-on-T phenomenon; Second-degree atrioventricular block (Mobitz II type), third-degree atrioventricular block or sick sinus syndrome without pacemaker implantation; Stroke or transient ischemic attack within the preceding 3 months; Severe hypertension (blood pressure ≥ 180\u002F110 mmHg); Severe respiratory tract infection (including common cold), or maximal voluntary ventilation (MMV) \\\u003C 30% of the predicted value; Severe hepatic dysfunction (Child-Pugh score \\> 9); Acute or chronic renal failure without renal replacement therapy: Acute kidney injury was defined as an absolute increase in serum creatinine ≥ 0.3 mg\u002FdL (≥26.5 μmol\u002FL) or a relative increase ≥ 50% from baseline, or urine output \\\u003C 0.5 mL\u002F(kg·h) for more than 6 consecutive hours. Chronic renal failure or uremia was defined as serum creatinine \\> 451 μmol\u002FL and estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m².\n* Severe coagulation disorders.\n* Refusal to participate in the trial.\n* Anticipated postoperative admission to the intensive care unit (ICU).","ALL","65 Years","80 Years",{"count":44,"type":45},84,"ESTIMATED","INTERVENTIONAL",[48],"NA","Postoperative sleep disturbance (PSD) is highly prevalent in elderly patients undergoing laparoscopic radical resection of colorectal cancer. Although remimazolam has shown favorable sedative properties and may alleviate perioperative stress, its effects on postoperative sleep architecture remain poorly understood. Polysomnography (PSG), the gold standard for objective sleep assessment, has not been widely used to evaluate these effects in this population. Therefore, this study employs a randomized controlled trial design to verify whether remimazolam is superior to propofol in preserving postoperative sleep quality, thereby offering more evidence-based options for anesthetic management in elderly patients undergoing laparoscopic colorectal cancer surgery.",[51],"Postoperative Sleep",[53],"postoperative sleep","NOT_YET_RECRUITING","2026-07-30",{"date":57,"type":58},"2026-07-31","ACTUAL",{"date":60,"type":45},"2026-09-01",{"date":62,"type":45},"2027-02-28",{"name":5,"class":6}]