[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04992572":3,"trial-entities:NCT04992572":107,"trial-summary:NCT04992572":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":15,"eligibility_criteria":52,"std_ages":64,"locations":67,"central_contacts":98,"overall_officials":102,"references":105,"see_also_links":106},"NCT04992572","61453","Study Comparing Local\u002F MAC Anesthesia in Lumbar Decompression","Randomized Study Comparing Local\u002F MAC Anesthesia to General for 1-3 Level Lumbar Decompressions","RECRUITING","2028-12-31","2026-03","2026-03-20","2021-12-01","Stanford University","OTHER",false,"Explore efficacy, complications, and other factors associated with anaesthetic choice- To evaluate the efficacy of local + MAC as an alternative anesthetic to general anesthesia and to analyze patients' outcomes and experiences.","100 Patients ages 40-95 with lumbar stenosis to be decompressed are randomized to undergo the procedure with either general anesthesia or local anesthetic with MAC.\n\nParticipants will be randomized to either group 1 General anesthesia or group 2 Local + MAC anesthetic group.\n\nGroup 1: General Anesthesia: Medically induced unconsciousness that suppresses reflexes and requires intubation (a tube inserted through the mouth and into the airway) to assist in breathing.\n\nGroup 2: Local + MAC: Local anesthetic (lidocaine) injected into the site of the incision\u002Fdissection with additional IV medication (Propofol) to achieve a state in which the patient is generally aware, but relaxed",[19],"Lumbar Spinal Stenosis",[],"INTERVENTIONAL","TREATMENT",[24],"EARLY_PHASE1",{"count":26,"type":27},100,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Propofol Injection","25mg Propofol administered by injection",[34],"General anesthesia",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Lidocaine Hydrochloride, Injectable","Licocaine administered locally via injection.",[39],"Monitored Anesthetic Care (MAC)\u002FLocal",[41,45],{"measure":42,"description":43,"timeFrame":44},"Change in Oswestry Disability Index (ODI) score","Scale is expressed as a percentage (0 to 100%). Higher score indicates more severe disability.","Basline through year 2",{"measure":46,"description":47,"timeFrame":44},"Change in patient reported pain","Measured on visual analog scale (VAS). Score range 0-10, 0= no pain and 10 = worst pain.",[],"ALL","40 Years","95 Years",{"inclusion":53,"exclusion":56,"raw_text":63},[54,55],"Ages 40-95","Appropriate for general anesthesia",[57,58,59,60,61,62],"Planned significant nerve root retraction","Previous fusion operation","Unable to comply with follow up","Patients with daily morphine equivalents or more 100mg","Patients with a known hypersensitivity to propofol or any of DIPRIVAN Injectable Emulsion components.","Patients with allergies to eggs, egg products, soybeans or soy products.","Inclusion Criteria:\n\nPatients with lumbar stenosis to be decompressed over 1-3 segments\n\n* Ages 40-95\n* Appropriate for general anesthesia\n\nExclusion Criteria:\n\n* Planned significant nerve root retraction\n* Previous fusion operation\n* Unable to comply with follow up\n* Patients with daily morphine equivalents or more 100mg\n* Patients with a known hypersensitivity to propofol or any of DIPRIVAN Injectable Emulsion components.\n* Patients with allergies to eggs, egg products, soybeans or soy products.",[65,66],"ADULT","OLDER_ADULT",[68,83],{"facility":69,"status":8,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":80},"Outpatient Surgery Center\u002FStanford Spine Clinic","Redwood City","California","94063","United States",[75],{"name":76,"role":77,"phone":78,"email":79},"Sarah Miller, MS","CONTACT","650-725-7984","Sarahmi@stanford.edu",{"lat":81,"lon":82},37.48522,-122.23635,{"facility":84,"status":8,"city":70,"state":71,"zip":85,"country":73,"contacts":86,"geoPoint":97},"Stanford Outpatient surgery center","94608",[87,91,94],{"name":88,"role":77,"phone":89,"email":90},"Susmita Chatterjee, MS\u002FCCRP","6504979271","susmitac@stanford.edu",{"name":92,"role":77,"phone":89,"email":93},"Agnes Ith, MD","mith@stanford.edu",{"name":95,"role":96},"Todd F Alamin, MD","PRINCIPAL_INVESTIGATOR",{"lat":81,"lon":82},[99],{"name":100,"role":77,"phone":78,"email":101},"Sarah Miller, MAS","sarahmi@stanford.edu",[103],{"name":104,"affiliation":13,"role":96},"Todd Alamin, MD",[],[],{"nct_id":4,"conditions":108,"biomarkers":109},[19],[],{"nct_id":4,"found":111,"summary":112,"prompt_version":122},true,{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an interventional study where 100 participants aged 40-95 will be randomly assigned to receive either general anesthesia or local anesthesia with Propofol for their lumbar decompression surgery.","completed","Study Comparing Local\u002FMAC Anesthesia in Lumbar Decompression","This study is looking at different types of anesthesia for people having surgery for lumbar spinal stenosis (a narrowing of the spinal canal in the lower back). Researchers want to see if using a local anesthetic (Lidocaine) combined with a relaxing medication (Propofol) is as effective and safe as general anesthesia (being completely asleep). You could be eligible if you are between 40 and 95 years old and need surgery for lumbar stenosis in 1 to 3 segments of your spine. The study will measure changes in your disability (using the Oswestry Disability Index score) and your pain levels for up to two years after surgery to see how well each anesthesia method works. The current recruitment status is unclear, but the study plans to enroll 100 participants.","Participants will be followed for changes in disability and pain from the start of the study through year 2.",128,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]