[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654319":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":51,"studyPopulation":51,"armGroups":58,"interventions":71,"overallOfficials":81,"centralContacts":85,"locations":91,"responsibleParty":106,"collaborators":51,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":51,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":51,"enrollmentInfo":118,"targetDuration":51,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":51,"overallStatus":129,"whyStopped":51,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Mayo Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":51},[9],{"measure":10,"description":11,"timeFrame":12},"Peak Intraoperative Serum Lactate","Highest intraoperative serum lactate concentration measured during surgery. Serum lactate will be analyzed as a continuous marker of tissue perfusion.","Intraoperatively, from initiation of lactate monitoring through final wound closure",[14,17,21,25,29,33,37,41,45,48],{"measure":15,"description":16,"timeFrame":12},"Incidence of Elevated Intraoperative Serum Lactate","Number of patients with presence of serum lactate greater than 2.0 mmol\u002FL at any time during surgery.",{"measure":18,"description":19,"timeFrame":20},"Postoperative Myocardial Injury After Noncardiac Surgery","Presence of postoperative myocardial injury after noncardiac surgery, defined as cardiac troponin greater than the 99th percentile of the upper reference limit and not attributable to a nonischemic cause.","Within 30 days after surgery",{"measure":22,"description":23,"timeFrame":24},"Postoperative Acute Kidney Injury","Number of patients to be diagnosed with new acute kidney injury during postoperative hospitalization, based on KDIGO creatinine, urine output, renal replacement therapy, or hemodialysis criteria as specified in the protocol.","During postoperative hospitalization, up to 30 days after surgery",{"measure":26,"description":27,"timeFrame":28},"Proportion of Intraoperative Hypotension","Duration of intraoperative MAP less than 85 mmHg divided by total surgical length, expressed as a percentage.","Intraoperatively, from surgical incision to turnover to anesthesia",{"measure":30,"description":31,"timeFrame":32},"Volume of Blood Transfusion","Total volume of blood transfusion, stratified by packed red blood cells, fresh frozen plasma, cryoprecipitate, platelets, and cell saver.","During surgery and within 24 hours postoperatively",{"measure":34,"description":35,"timeFrame":36},"Length of ICU Stay","Postoperative time during which the participant requires ICU-level care, reported in days.","From ICU admission to discharge from ICU-level care, up to 30 days after surgery",{"measure":38,"description":39,"timeFrame":40},"Length of Hospital Stay","Time from anesthesia end until discharge to inpatient rehabilitation, skilled nursing facility, or home, reported in days.","From anesthesia end to hospital discharge, up to 30 days after surgery",{"measure":42,"description":43,"timeFrame":44},"Quality of Recovery 15 (QoR-15) Score","QoR-15 is an instrument that uses 15 questions regarding patient support, comfort, emotions, physical independence, and pain. Participants rate each question on a scale of 0 (none of the time) to 10 (all of the time).","14 days post-operatively",{"measure":46,"description":47,"timeFrame":20},"30-Day Readmission Rate","Number of patients to be readmitted to the hospital for any reason on or before postoperative day 30.",{"measure":49,"description":50,"timeFrame":20},"30-Day All-Cause Mortality","Incidence of death from any cause within 30 days of surgery",null,{"allocation":53,"interventionModel":54,"interventionModelDescription":51,"primaryPurpose":55,"observationalModel":51,"timePerspective":51,"maskingInfo":56},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":57,"maskingDescription":51,"whoMasked":51},"NONE",[59,65],{"label":60,"type":61,"description":62,"interventionNames":63},"Phenylephrine","ACTIVE_COMPARATOR","Participants assigned to this group will undergo elective complex spine surgery with intraoperative blood pressure support managed using phenylephrine as the assigned first-line vasopressor strategy.",[64],"Drug: Phenylephrine hydrochloride infusion",{"label":66,"type":67,"description":68,"interventionNames":69},"Norepinephrine","EXPERIMENTAL","Participants assigned to this group will undergo elective complex spine surgery with intraoperative blood pressure support managed using norepinephrine as the assigned first-line vasopressor strategy.",[70],"Drug: Norepinephrine bitartrate infusion",[72,77],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":51},"DRUG","Phenylephrine hydrochloride infusion","Phenylephrine hydrochloride will be prepared at a concentration of 40 mcg\u002FmL and initiated at 0.2 mcg\u002Fkg\u002Fmin. The infusion will be titrated intraoperatively to maintain MAP greater than 85 mmHg from surgical manipulation of vertebrae until final wound closure.",[60],{"type":73,"name":78,"description":79,"armGroupLabels":80,"otherNames":51},"Norepinephrine bitartrate infusion","Norepinephrine bitartrate will be prepared at a concentration of 16 mcg\u002FmL, equivalent to 8.47 mcg\u002FmL norepinephrine base, and initiated at 0.02 mcg\u002Fkg\u002Fmin. The infusion will be titrated intraoperatively to maintain MAP greater than 85 mmHg from surgical manipulation of vertebrae until final wound closure.",[66],[82],{"name":83,"affiliation":5,"role":84},"Eric Deloso, MD","PRINCIPAL_INVESTIGATOR",[86],{"name":87,"role":88,"phone":89,"phoneExt":51,"email":90},"Mariel Anne Reyes","CONTACT","904-953-4797","Reyes.Mariel@mayo.edu",[92],{"facility":5,"status":51,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":104},"Jacksonville","Florida","32224","United States","US",{"type":99,"coordinates":100},"Point",[101,102],-81.65565,30.33218,{"lat":102,"lon":101},[105],{"name":87,"role":88,"phone":89,"phoneExt":51,"email":90},{"type":84,"investigatorFullName":107,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"Eric Deloso","Principal Investigator","100654319","phase-4-phenylephrine-versus-norepinephrine-in-spine-surgery-a-prospective-randomized-superiority-comparative-effectiveness-trial-spines-100654319",false,"NCT07796282","Superiority of Phenylephrine Versus Norepinephrine in Complex Spine Surgery (SPiNeS)","Superiority of Phenylephrine Versus Norepinephrine in Complex Spine Surgery (SPiNeS): A Prospective Randomized Superiority Trial","Inclusion Criteria:\n\n* Scheduled for elective complex spine surgery including posterior fusion of 5 or more levels of the thoracic and\u002For lumbar region.\n* ASA physical status classification I-III.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Known allergies or contraindication to NE or PE.\n* Pregnant or breastfeeding women.\n* Emergency surgeries.\n* Persistent atrial fibrillation\n* LVEF \\\u003C 40%\n* Moderate or severe valvular dysfunction\n* RVSP ≥ 60 mm Hg\n* Liver failure or cirrhosis\n* eGFR \\\u003C 15 and\u002For on hemodialysis\n* Minimally invasive or endoscopic surgeries","ALL","18 Years",{"count":119,"type":120},50,"ESTIMATED","INTERVENTIONAL",[123],"PHASE4","The purpose of this research is to compare two commonly used medications, phenylephrine and norepinephrine, that are used to treat low blood pressure during complex spine surgery. The goal is to determine whether one medication better maintains blood flow to the body's organs during surgery and whether it leads to better recovery and fewer complications after surgery.",[126,127,128],"Spine Surgery","Intraoperative Hypotension","Tissue Perfusion","NOT_YET_RECRUITING","2026-08-31",{"date":132,"type":133},"2026-09-02","ACTUAL",{"date":135,"type":120},"2026-09",{"date":137,"type":120},"2028-05",{"name":5,"class":6},1]