[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640937":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":41,"locations":46,"responsibleParty":50,"collaborators":46,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":46,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":46,"enrollmentInfo":61,"targetDuration":46,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":76,"whyStopped":46,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":46},{"fullName":5,"class":6},"Qianfoshan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Opioid-free anaesthesia group","ACTIVE_COMPARATOR","In the OFA group, anaesthesia will be induced with 1.5-2.5 mg\u002Fkg propofol, 0.3-0.5 mg\u002Fkg esketamine, and 0.6-1.0 mg\u002Fkg rocuronium. Endotracheal intubation or laryngeal mask placement will be performed when the BIS value is observed at 40-60.",[13],"Drug: OFA group",{"label":15,"type":10,"description":16,"interventionNames":17},"opioid-based anaesthesia group","In the OBA group, anaesthesia will be induced with 1.5-2.5 mg\u002Fkg propofol, 0.6-1.0 mg\u002Fkg rocuronium, and 0.3-0.5 μg\u002Fkg sufentanil. Endotracheal intubation or laryngeal mask airway insertion will be performed when the BIS value decreases to 40-60.",[18],"Drug: OBA group",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","OFA group","In the OFA group, anaesthesia will be induced with 1.5-2.5 mg\u002Fkg propofol, 0.3-0.5 mg\u002Fkg esketamine, and 0.6-1.0 mg\u002Fkg rocuronium. Endotracheal intubation or laryngeal mask placement will be performed when the BIS value is observed at 40-60. Intraoperative continuous intravenous infusion of 2-6 mg\u002Fkg\u002Fh propofol, 0.5-1.0 μg\u002Fkg\u002Fh dexmedetomidine, 0.2-0.5 mg\u002Fkg\u002Fh esketamine, 5-6 μg\u002Fkg\u002Fmin rocuronium bromide, 20-100 μg\u002Fkg\u002Fmin esmolol, and inhaled 1% sevoflurane will be utilized to maintain anaesthesia. At the end of the procedure (after the last suture), all maintenance drugs will be discontinued. Afterwards, 8 mg of ondansetron and 0.2 mg\u002Fkg esketamine-assisted sufentanil will be intravenously administered. Postoperative analgesia will be performed by using an intravenous patient-controlled analgesia pump consisting of 1.5 mg\u002Fkg esketamine and 16 mg of ondansetron. The volume will be adjusted to 100 mL in 0.9% normal saline; moreover, the continuous infusion rate will be set at 2 mL\u002Fh, an",[9],[26],"Opioid-free anaesthesia",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"OBA group","In the OBA group, anaesthesia will be induced with 1.5-2.5 mg\u002Fkg propofol, 0.6-1.0 mg\u002Fkg rocuronium, and 0.3-0.5 μg\u002Fkg sufentanil. Endotracheal intubation or laryngeal mask airway insertion will be performed when the BIS value decreases to 40-60. During surgery, 2-6 mg\u002Fkg\u002Fh propofol, 0.2-1.0 μg\u002Fkg\u002Fmin remifentanil, and 5-6 μg\u002Fkg\u002Fmin rocuronium will be continuously pumped to maintain anaesthesia. Both groups will receive inhalation of 1% sevoflurane during anaesthesia maintenance. At the end of the procedure (after the last suture), all maintenance drugs will be discontinued. Afterwards, 8 mg of ondansetron and 0.15 μg\u002Fkg sufentanil will be intravenously injected. Postoperative analgesia will be performed by using an intravenous patient-controlled analgesia pump; the formulation will involve 2 μg\u002Fkg sufentanil and 16 mg of ondansetron, which will be diluted to 100 mL with 0.9% normal saline. Moreover, the background infusion rate will be set at 2 mL\u002Fh, and the lockout interval will be 1",[15],[32],"opioid-based anaesthesia",[34,38],{"name":35,"affiliation":36,"role":37},"Yongtao Sun","Shandong First Medical University","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":36,"role":40},"Min Zhang","STUDY_CHAIR",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Yongtao Sun, PHD. MD.","CONTACT","+8618660795201",null,"science2020@hotmail.com",{"name":39,"role":44,"phone":46,"phoneExt":46,"email":49},"Zhangmin201609@outlook.com",{"type":37,"investigatorFullName":35,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"Deputy Director","100640937","phase-1-opioid-free-anesthesia-and-postoperative-delirium-100640937",false,"NCT07603596","Opioid-free Anesthesia and Postoperative Delirium","Effect of Opioid-free Anesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery","Inclusion Criteria:\n\n1. Patients who plan to undergo elective gastrointestinal surgery under general anaesthesia\n2. Age ≥65 years\n3. American Society of Anaesthesiologists (ASA) grade I-III\n4. Body mass index (BMI) of 18.0-30.0 kg\u002Fm²\n5. Frailty: mFI ≥ 0.27\n6. Signed informed consent\n\nExclusion Criteria:\n\n1. Patients undergoing emergency surgery\n2. Patients with language disorders or severe hearing or vision impairment that prevent communication\n3. Patients with a history of neurological and psychiatric disorders, including Alzheimer's disease (AD), other types of dementia, stroke, and psychosis\n4. Patients with long-term use of psychotropic medications (such as clozapine, risperidone, olanzapine, haloperidol, and chlorpromazine)\n5. Patients who have undergone cardiac surgery or craniocerebral surgery within the past year\n6. Patients who have participated in other relevant clinical trials within the past 3 months\n7. Patients with preoperative cognitive impairment (Telephone Interview for Cognitive Status-modified (TICS-m) score ≤ 27), as determined via the TICS-M test\n8. Each patient can be included only once, regardless of whether the reason for the second surgery is related to the primary cause\n9. Let me know if you need this in a different bullet style (e.g., asterisks) or with indentation adjustments.","ALL","65 Years",{"count":62,"type":63},174,"ESTIMATED","INTERVENTIONAL",[66],"PHASE1","Postoperative delirium (POD) is a common acute and transient form of brain dysfunction in elderly patients following surgery that can lead to serious adverse clinical outcomes and even death. Although existing studies have preliminarily investigated the effects of opioid-free anaesthesia (OFA) on POD, high-quality evidence on these effects for elderly patients undergoing gastrointestinal surgery remains limited. This study aims to investigate the effects of OFA on the development of POD in elderly patients following gastrointestinal surgery. This single-centre, prospective, randomized controlled trial will be conducted at the First Affiliated Hospital of Shandong First Medical University, China. A total of 654 patients aged 65 years or older who are scheduled for elective gastrointestinal surgery will be randomly allocated to receive either opioid-free anaesthesia (OFA; dexmedetomidine, esmolol, and esketamine) or conventional opioid-based anaesthesia (OBA). The primary outcome is the incidence of POD 7 days after surgery. The secondary outcomes are all-cause mortality within 30 days after surgery, intraoperative haemodynamic changes, the 15-item quality of recovery (QoR-15) scores at 24 h, 48 h, and 72 h after surgery, complications during postoperative hospitalization, pain numerical rating scale (NRS) score at 72 h after surgery, incidence of nausea and vomiting at 72 h after surgery, morphine milligram equivalent for analgesics at 72 h after surgery, duration of anaesthesia (from induction to discontinuation), duration of surgery (from skin incision to the last suture), duration of post-anaesthesia care unit (PACU) stay, and length of hospital stay. The results of this study may shed light on the effects of OFA on POD in elderly patients undergoing gastrointestinal surgery. The study is designed on the basis of the following key hypothesis: the use of opioid drugs for anaesthesia may increase the risk of POD through mechanisms such as blood-brain barrier destruction, neuroinflammatory responses, and central nervous system depression. Through the single-centre and prospective design of this randomized controlled trial, this study will directly analyse differences in the effects of OFA and conventional OBA on the incidence of POD, haemodynamic stability and long-term cognitive function in elderly patients.",[69,70],"Postoperative Delirium","Gastrointestinal Tumors",[72,73,74,75],"elderly patients","opioid-free anaesthesia","postoperative delirium","gastrointestinal surgery","NOT_YET_RECRUITING","2026-05-16",{"date":79,"type":80},"2026-05-22","ACTUAL",{"date":82,"type":63},"2026-05-01",{"date":84,"type":63},"2028-06-30",{"name":5,"class":6}]