[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07365800":3,"trial-entities:NCT07365800":82,"trial-summary:NCT07365800":85},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":65,"locations":68,"central_contacts":78,"overall_officials":79,"references":80,"see_also_links":81},"NCT07365800","2130514","The MDK Study: Using a Combination of Methadone-dexmedetomidine-ketamine for Postoperative Pain Control in Patients Undergoing Complex Spine Surgeries.","ENROLLING_BY_INVITATION","2027-06","2026-06","2026-06-11","2026-04-24","University of Missouri-Columbia","OTHER",true,"This study will investigate whether a combination of three anesthetic medications will reduce intraoperative and postoperative pain in patients undergoing complex spine surgery, and whether it will reduce the use of opioid pain medication after surgery.","Dexmedetomidine, methadone and ketamine offer benefits when used as adjuncts in complex spine surgeries. Dexmedetomidine is reported to attenuate intraoperative stress responses without interfering with neuromonitoring while potentially improving postoperative pain control and reducing opioid consumption in complex spine surgery. Methadone use intraoperatively improves postoperative pain control and reduced opioid requirements following complex spine surgery. Consensus guidelines from the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists support the use of ketamine in acute pain management in surgeries like spine surgery. Perioperative ketamine use in spine surgery results in lower pain scores and reduced opioid utilization postoperatively. The use of dexmedetomidine, methadone and ketamine as adjuncts may improve postoperative pain control while reducing opioid requirements, lowering stress responses, and without significantly impacting neuromonitoring in complex spine surgery or increasing drug related adverse events.",[18],"Spine Surgery",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE4",{"count":25,"type":26},248,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","Methadone-dexmedetomidine-ketamine combination","Combination of Methadone-dexmedetomidine-ketamine administered during spine surgery for intra- and post-operative pain management.",[33],"Intervention",[35],{"measure":36,"description":37,"timeFrame":38},"Effect of the MDK combination during surgery on postoperative opioid consumption","Determine if use of dexmedetomidine, methadone, and ketamine given together intraoperatively has an effect on postoperative opioid consumption following complex spine surgery of 3 or more levels","72 hours postoperatively",[40,44],{"measure":41,"description":42,"timeFrame":43},"Effect of MDK combination on overall postoperative pain scores.","Determine whether dexmedetomidine, methadone, and ketamine given together intraoperatively has an effect on overall postoperative pain scores following complex spine surgery compared to standard therapy. Pain scores using the visual analog scale, collected by nursing staff during hospital stay, will be used.","72 hours after surgery",{"measure":45,"description":46,"timeFrame":38},"Incidence of opioid-related adverse events","Evaluate incidence of opioid related adverse events in patients treated with intraoperative combination of methadone, dexmedetomidine and ketamine compared to standard therapy. The number of adverse events per group will be collected.","ALL","18 Years","79 Years",false,{"inclusion":52,"exclusion":57,"raw_text":64},[53,54,55,56],"Age 18-79 years of age","Patients undergoing complex spine surgery, defined as 3 or more levels","English-speaking","Able to consent for themselves",[58,59,60,61,62,63],"Patients who are unable to consent to study participation in English","Patients who are unable to consent for themselves.","Patients with prolonged QT syndrome","Pregnancy","Preoperative ECG will be performed in preoperative holding as part of standard of care to assess for prolonged QTc prior to administration of methadone as part of SOC.","Pregnancy test will be performed as part of SOC on the day of surgery.","Inclusion criteria:\n\n* Age 18-79 years of age\n* Patients undergoing complex spine surgery, defined as 3 or more levels\n* English-speaking\n* Able to consent for themselves\n\nExclusion criteria:\n\n* Patients who are unable to consent to study participation in English\n* Patients who are unable to consent for themselves.\n* Patients with prolonged QT syndrome\n* Pregnancy\n\nAdditional screening measures:\n\n* Preoperative ECG will be performed in preoperative holding as part of standard of care to assess for prolonged QTc prior to administration of methadone as part of SOC.\n* Pregnancy test will be performed as part of SOC on the day of surgery.",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":70,"city":71,"state":72,"zip":73,"country":74,"geoPoint":75},"University Hospital","Columbia","Missouri","65212","United States",{"lat":76,"lon":77},38.95171,-92.33407,[],[],[],[],{"nct_id":4,"conditions":83,"biomarkers":84},[18],[],{"nct_id":4,"found":14,"summary":86,"prompt_version":96},{"design":87,"status":88,"heading":89,"summary":90,"follow_up":91,"word_count":92,"commitments":93,"compensation":94,"drugs_mentioned":95},"This is an interventional study planning to enroll 248 participants. It is not specified if it is randomized or blinded.","completed","The MDK Study: Pain Control in Complex Spine Surgeries","This study is investigating if a combination of three medications—methadone, dexmedetomidine, and ketamine—can help manage pain during and after complex spine surgeries. Researchers want to see if this combination reduces the amount of opioid pain medication you might need after surgery. You could be eligible if you are between 18 and 79 years old, are having complex spine surgery (involving 3 or more levels), and can speak English and consent for yourself. The main goal is to measure how much opioid pain medication is used in the 72 hours after surgery. The current status of this study is unclear.","The primary endpoint measures opioid consumption at 72 hours postoperatively, indicating a follow-up period of at least 72 hours after surgery.",99,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]