[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641840":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":55,"studyPopulation":55,"armGroups":65,"interventions":78,"overallOfficials":55,"centralContacts":55,"locations":55,"responsibleParty":88,"collaborators":55,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":55,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":55,"enrollmentInfo":101,"targetDuration":55,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":116,"whyStopped":55,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":55},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":55},[9],{"measure":10,"description":11,"timeFrame":12},"Opioid consumption","Total morphine equivalent consumption during the first 24 hours after surgery","From end of surgery to 24 hours after surgery",[14,18,22,25,29,33,37,41,44,48,51],{"measure":15,"description":16,"timeFrame":17},"Pain Scores (NRS)","Pain intensity will be assessed after recovery and 1, 6, 24, 48, 72 hours after surgery using the Numeric Rating Scale (NRS) daily, including NRS at rest, NRS on movement.","From end of surgery to postoperative 72 hours",{"measure":19,"description":20,"timeFrame":21},"Time to First Rescue Analgesia","The exact time (in hours and minutes) from the end of surgery to the administration of the first rescue analgesic will be recorded.","From end of surgery to the administration of the first rescue analgesic",{"measure":23,"description":24,"timeFrame":17},"Total Analgesic Consumption","The cumulative amount of all pain medications (opioid and non-opioid, oral and intravenous) administered within 3 days postoperatively, including total morphine equivalent consumption during 48 hours and 72 hours after surgery.",{"measure":26,"description":27,"timeFrame":28},"Time to first postoperative flatus","The exact time (in hours and minutes) from the end of surgery to the first postoperative flatus will be recorded.","Up to 72 hours postoperatively",{"measure":30,"description":31,"timeFrame":32},"Quality of recovery","The quality of recovery after surgery will be evaluated using Quality of Recovery-15 (QoR-15) at 1 day after surgery.","At 1 day after surgery",{"measure":34,"description":35,"timeFrame":36},"Sleep quality","The sleep quality after surgery will be evaluated daily for the first 3 postoperative days using Richards-Campbell Sleep Questionnaire (RCSQ).","From end of surgery to 3 days after surgery",{"measure":38,"description":39,"timeFrame":40},"Postoperative anxiety","The anxiety after surgery will be evaluated daily for the first 2 postoperative days using Visual Analog Scale for Anxiety (NRS-anxiety).","From end of surgery to 2 days after surgery",{"measure":42,"description":43,"timeFrame":36},"Postoperative delirium","The postoperative delirium will be evaluated twice a day for the first 3 postoperative days using 3-Minute Diagnostic Interview for CAM (3D-CAM).",{"measure":45,"description":46,"timeFrame":47},"Length of Hospital Stay","Length of hospital stay measured as the number of days from the date of surgery to hospital discharge.","Through hospital discharge, up to 14 days",{"measure":49,"description":50,"timeFrame":36},"Adverse Effects","Incidence of nausea or vomiting, acute urinary retention, drowsiness, pruritus, and dizziness or any other reported complications will be recorded.",{"measure":52,"description":53,"timeFrame":54},"Gut microbiota","Gut microbiota diversity (α and β), and correlation between relative abundance of specific microbial taxa and the effect of opioid-sparing anesthesia will be analyzed.","From 1 day before surgery to 2 days after surgery",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":55,"primaryPurpose":59,"observationalModel":55,"timePerspective":55,"maskingInfo":60},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":61,"maskingDescription":55,"whoMasked":62},"DOUBLE",[63,64],"PARTICIPANT","OUTCOMES_ASSESSOR",[66,72],{"label":67,"type":68,"description":69,"interventionNames":70},"Group 1：Opioid-Sparing Anesthesia","EXPERIMENTAL","Participants assigned to Group 1 will receive opioid-sparing anesthesia strategy. Continuous intravenous infusion of ketamine (5 μg\u002Fkg\u002Fmin) and dexmedetomidine (0.6 μg\u002Fkg\u002Fh) will be initiated from induction and maintained until one hour before the anticipated end of surgery. If needed during surgery, rescue analgesia with dexmedetomidine (0.4 μg\u002Fkg, i.v.) or ketamine (5 mg, i.v.) may be administered as clinically indicated.",[71],"Drug: Opioid-Sparing Protocol",{"label":73,"type":74,"description":75,"interventionNames":76},"Group 2：Routine Anesthesia","ACTIVE_COMPARATOR","Participants assigned to Group 2 will receive routine anesthesia management. During induction, fentanyl 100 μg will be administered intravenously. If needed during surgery, rescue analgesia with hydromorphone may be administered as clinically indicated.",[77],"Drug: Routine anesthesia protocol",[79,84],{"type":80,"name":81,"description":82,"armGroupLabels":83,"otherNames":55},"DRUG","Opioid-Sparing Protocol","The opioid-sparing anesthesia protocol consists of continuous intravenous infusion of ketamine (5 μg\u002Fkg\u002Fmin) and dexmedetomidine (0.6 μg\u002Fkg\u002Fh) during general anesthesia. If needed during surgery, rescue analgesia with dexmedetomidine (0.4 μg\u002Fkg, i.v.) or ketamine (5 mg, i.v.) may be administered as clinically indicated.",[67],{"type":80,"name":85,"description":86,"armGroupLabels":87,"otherNames":55},"Routine anesthesia protocol","Routine anesthesia consisting of standard general anesthetic management per institutional practice, which include opioid-based analgesia as clinically indicated, which is fentanyl 100 μg during induction, and if needed during surgery, rescue analgesia with hydromorphone may be administered as clinically indicated.",[73],{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"PRINCIPAL_INVESTIGATOR","Jingping Wang, MD, Ph.D.","Associate Professor, Harvard Medical School","100641840","phase-2-effect-of-opioid-sparing-anesthesia-on-postoperative-opioid-consumption-and-pain-in-elderly-patients-undergoing-spine-surgery-100641840",false,"NCT07588802","Effect of Opioid-Sparing Anesthesia on Postoperative Opioid Consumption and Pain in Elderly Patients Undergoing Spine Surgery","Effect of Opioid-Sparing Anesthesia on Postoperative Opioid Consumption and Pain in Spine Surgery","Inclusion Criteria:\n\n* Aged ≥ 65 years\n* Undergoing multilevel level (≥2 levels) spine surgery under general anesthesia\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Diagnosed with severe cognitive impairment or psychiatric disorders that impair participation or communication\n* Pregnant or breastfeeding\n* Patients with contraindications to any of the medications in the study protocol (unstable angina, recent myocardial infarction, cerebral or aortic aneurysms, increased intracranial pressure, increased intraocular pressure, psychosis or schizophrenia, pheochromocytoma, epilepsy, second- or third-degree atrioventricular block, bradycardia (heart rate \\\u003C 50bpm), liver failure, hypotension (systolic BP \\\u003C80 mmHg))\n* Drug or alcohol abuse\n* Refuse to participate","ALL","65 Years",{"count":102,"type":103},120,"ESTIMATED","INTERVENTIONAL",[106],"PHASE2","The goal of this clinical trial is to learn if an anesthesia management strategy called opioid-sparing anesthesia could help reduce postoperative opioid consumption, pain intensity and enhance recovery in elderly patients undergoing spine surgery. The main questions it aims to answer are:\n\nDoes opioid-sparing anesthesia reduce postoperative opioid consumption?\n\nDose opioid-sparing anesthesia improve postoperative pain and enhance recovery?\n\nResearchers will compare opioid-sparing anesthesia to routine anesthesia which is used most common in clinical practice to see if opioid-sparing anesthesia lead to fewer postoperative opioid consumption and better pain and recovery outcomes.\n\nParticipants will randomly assigned to one of two groups. One group will receive opioid-sparing anesthesia management , while the other group will receive routine anesthesia management during general anesthesia.\n\nParticipants will provide two rectal swab samples for analysis, complete five questionnaires once preoperatively, and then complete five questionnaires daily for three days postoperatively.",[109,110],"Opoid Managment","Pain Management",[112,10,113,114,115],"Opioid-sparing anesthesia","postoperative pain","elderly patients","spine surgery","NOT_YET_RECRUITING","2026-09-02",{"date":119,"type":120},"2026-09-08","ACTUAL",{"date":122,"type":103},"2026-09",{"date":124,"type":103},"2027-05",{"name":5,"class":6}]