[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spine-surgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spine-surgery":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,54,86,113,137,164,191,217,240,273],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100644078","phase-4-investigation-of-the-preventia-irrigation-solution-for-reducing-bacteria-in-spinal-surgery-with-implants---a-comparative-study-100644078",false,"NCT07667036","Investigation of the PREVENTIA® Irrigation Solution for Reducing Bacteria in Spinal Surgery With Implants - A Comparative Study","Prevention of Bacterial Contamination in Spinal Fusion Surgery Using Polyhexanide-Poloxamer Wound Irrigation - a Randomized Clinical Trial","PROTECT-SPINE","Inclusion Criteria:\n\n* Age more than 18 years\n* Plan to undergo elective spinal fusion surgery (including thoracic and lumbar vertebrae, and sacrum and coccyx)\n* Informed consent as documented by signature\n\nExclusion Criteria:\n\n* Emergency spine surgery\n* Previous spine fusion surgery\n* Unable to follow the comply with the study procedure or provide informed consent\n* Known allergies to any of the products used in the trial\n* Female gender\n* Current or recent (last 14 days) antibiotic therapy\n* Participation in another trial with an antimicrobial substance within the 30 days preceding and during the present trial\n* Known or suspected drug or alcohol abuse\n* Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject\n* Evidence or suspicion of preexisting infection, defined as:\n\nCurrent local infection (or active treatment) involving the spine or adjacent soft tissues (e.g. spondylodiscitis, epidural or paravertebral abscess, cellulitis at the intervention site) diagnosed clinically or by imaging prior to intervention; Active systemic bacterial\u002Ffungal infection requiring antimicrobial therapy","MALE","18 Years",{"count":20,"type":21},114,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Spinal surgery carries a risk of surgical wound infections (i.e., the entry of bacteria). Despite various preventive measures, such infections continue to occur, particularly in operations involving implants. In this study, we would like to investigate whether rinsing the surgical wound with a special irrigation solution called PREVENTIA® can reduce the number of bacteria in the wound during the operation.",[27,28,29],"Surgical Site Infection (SSI)","Spine Surgery","Surgical Site Infection Prevention",[31,32,33,34,35,36,37,38,39,40],"SSI","surgical site infection","spinal surgery","spinal fusion surgery","preventia","polyhexanide","poloxamer","biofilm","infection prevention","spondylodesis","NOT_YET_RECRUITING","2026-06-24",{"date":44,"type":45},"2026-06-29","ACTUAL",{"date":47,"type":21},"2027-01-01",{"date":49,"type":21},"2028-12-31",{"name":51,"class":52},"Universität Luzern","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100639092","low-dose-rocuronium-maintenance-during-spine-surgery-with-intraoperative-neurophysiological-monitoring-100639092","NCT07627750","Low-Dose Rocuronium Maintenance During Spine Surgery With Intraoperative Neurophysiological Monitoring","A Randomized Controlled Trial Comparing Low-Dose Rocuronium Maintenance Versus Discontinuation After Induction on Motor Evoked Potential Quality During Spine Surgery With Intraoperative Neurophysiological Monitoring","ROC-IONM","Inclusion Criteria:\n\n\\- 1. Patients aged 18 years or older. 2. Patients scheduled for spine surgery under general anesthesia. 3. Patients undergoing spine surgery with intraoperative neurophysiological monitoring, including motor evoked potentials and\u002For somatosensory evoked potentials.\n\n4\\. Patients who agree to participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Pre-existing central or peripheral neurological disease that may affect intraoperative neurophysiological monitoring, such as quadriplegia, persistent sensory disorder, sequelae of stroke, or polyneuropathy.\n\n  2\\. History of epilepsy or electroencephalographic disorder. 3. Use of neuropsychiatric drugs, strong sedatives, or drugs affecting neuromuscular or neurological conduction within 48 hours before surgery.\n\n  4\\. Decompensated cardiovascular disease or severe respiratory disease that may affect emergence or anesthetic drug metabolism.\n\n  5\\. Contraindication to intraoperative neurophysiological monitoring. 6. Contraindication to rocuronium. 7. Refusal to participate or withdrawal of consent at any time..","ALL",{"count":64,"type":21},62,[66],"NA","This randomized controlled trial will compare two strategies for rocuronium use during general anesthesia for spine surgery with intraoperative neurophysiological monitoring. Participants undergoing spine surgery under general anesthesia with motor evoked potential and\u002For somatosensory evoked potential monitoring will be randomized to either low-dose rocuronium maintenance targeting a train-of-four ratio of 0.60 to less than 0.90, or no rocuronium maintenance after induction.\n\nThe main objective is to compare the effects of these two strategies on the quality of intraoperative neurophysiological monitoring, especially motor evoked potential signals. Secondary objectives include comparing surgical field conditions, unwanted patient movement, emergence and extubation times, early respiratory events, and new postoperative neurological deficits.\n\nThe study will be conducted at the Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital, Hanoi, Vietnam. The planned sample size is 62 participants, with 31 participants in each group.",[28,69,70],"Intraoperative Neurophysiological Monitoring","Neuromuscular Blockade",[72,73,74,75,28,69,76],"Rocuronium","Motor Evoked Potentials","Somatosensory Evoked Potentials","Train-of-Four Ratio","Total Intravenous Anesthesia","2026-05-30",{"date":79,"type":45},"2026-06-04",{"date":81,"type":21},"2026-06",{"date":83,"type":21},"2028-12",{"name":85,"class":52},"Bach Mai Hospital",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":53},"100640030","impact-of-nol---nociception-level-index-intraoperative-monitoring-on-perioperative-outcomes-in-spine-surgery---a-quality-improvement-pilot-100640030","NCT07608276","Impact of NOL - Nociception Level Index Intraoperative Monitoring on Perioperative Outcomes in Spine Surgery - a Quality Improvement Pilot","Inclusion Criteria:\n\n* Age \\> 18 years old.\n* ASA I-III\n* Elective spine surgery (laminectomy, spinal fusion, and disc replacement) under general anesthesia.\n* Opioid tolerant and patients with documented chronic pain may be included\n* Patient able to provide informed consent\n\nExclusion Criteria:\n\n* • Use of any type of anesthesia other than general anesthesia (neuraxial, epidural analgesia or local regional anesthesia)\n\n  * Use of intraoperative methadone\n  * Non-sinus heart rate\n  * Pregnancy\u002Flactation\n  * Chronic use of psychoactive drugs within 90 days prior to surgery\n  * Patients currently using IV opioids (IV drug abuse)\n  * Allergy or intolerance to any of the study anesthesia related drugs\n  * History of severe cardiac arrhythmias within the last 12 months\n  * Surgeries less than 1.5 hours (from incision to extubation)",{"count":93,"type":21},100,[66],"The objective of this study is to evaluate the clinical impact of the NOL nociception level index monitoring on intraoperative and post operative patient outcomes and institutional metrics when used to guide intraoperative analgesia dosing in patients undergoing spine surgery under general anesthesia when compared to a case controlled retrospective cohort.",[28,97,98],"Pain After Surgery","Anesthesia , Analgesia",[100,101,102,103],"nociception","pain","NOL nociception level index","quality improvement","2026-05-20",{"date":106,"type":45},"2026-05-27",{"date":108,"type":21},"2026-05",{"date":110,"type":21},"2027-03",{"name":112,"class":52},"Medasense Biometrics Ltd",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":62,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":53},"100579707","an-open-parallel-group-randomized-medical-device-study-to-assess-the-usability-and-performance-of-surgify-halotm-in-spine-surgery-versus-state-of-art-rosen-burr-100579707","NCT06827795","An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)","Inclusion Criteria:\n\n* Disease of the spine requiring surgery with bone removal\n\n  * Ability to understand the purpose and risks of the study and to give written informed consent\n  * Age 21-85 years\n\nExclusion Criteria:\n\n* Abnormalities of bone tissue\n* Vulnerable patients (such as prisoners, Individuals with limited or no reading skills, decisionally impaired persons, persons in nursing homes, patients in emergency), and pregnant women\n* Allergy or hypersensitivity to medical-grade stainless steel or any alloying components\n* Problems with blood clotting","21 Years","85 Years",{"count":122,"type":21},30,[66],"The purpose of this research study is to:\n\ntest the usability and performance of the medical device Surgify Halo ™ in spine surgery test the level of \"chattering \" during the use of the device test the cutting performance of Surgify Halo™in comparison to the usual drill bit used in spine surgery ( Rosen burr).\n\nThis medical device is available for its indications for shaping and removal of hard tissue and bone in neurosurgical, spinal, ENT, and general surgical procedures.\n\nThe target is to enroll 30 participants in this study.",[28],"RECRUITING","2026-04-24",{"date":129,"type":45},"2026-04-30",{"date":131,"type":45},"2026-02-19",{"date":133,"type":21},"2026-12-31",{"name":135,"class":136},"Surgify Medical Oy","INDUSTRY",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":160,"leadSponsor":162,"locationsCount":4},"100608471","phase-2-intraoperative-placement-of-vancomycin-impregnated-calcium-sulfate-beads-conjugated-with-analgesics-to-improve-spine-surgery-outcomes-100608471","NCT07201987","Intraoperative Placement of Vancomycin-impregnated Calcium Sulfate Beads Conjugated With Analgesics to Improve Spine Surgery Outcomes","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Able to understand and provide consent in English\n* Undergoing elective lumbar spinal decompression and fusion surgery at one or two levels\n\nExclusion Criteria:\n\n* History of allergy or hypersensitivity to morphine, bupivacaine, or calcium sulfate.\n* Active systemic or localized infection at the surgical site.\n* History of chronic opioid dependence or opioid use disorder (as it may confound pain assessment).\n* Patients with severe renal or hepatic impairment (due to altered metabolism of analgesics and risk of complications from analgesic side effects).\n* Pregnant or breastfeeding individuals.\n* Filling of defects that are intrinsic to the stability of the bony structure\n* Severe vascular or neurological disease\n* Uncontrolled diabetes\n* Severe degenerative bone disease\n* Hypercalcemia",{"count":93,"type":21},[145],"PHASE2","The goal of this clinical trial is to learn if using calcium sulfate beads that contain vancomycin (an antibiotic) and pain-relieving medicines during spine surgery can improve recovery compared to standard care with intravenous (IV) morphine and local pain medicines.\n\nResearchers want to know if the sustained release formulation of morphine from these calcium sulfate beads affect:\n\n* Postoperative length of stay\n* Postoperative pain scores\n* Postoperative narcotic analgesic requirements\n\nAll participants in this study will already be scheduled to have spine surgery as part of their regular medical care. During surgery, participants will be assigned to receive either intraoperative placement of calcium sulfate beads with vancomycin alone or vancomycin with morphine and bupivacaine. All patients will still have access to standard of care with IV and PO pain regimens. Participants will then be followed after surgery to measure their pain, recovery, and medication use.\n\nParticipation is voluntary, and choosing not to join will not affect a person's medical care.",[28,148],"Postoperative Pain Management",[150,151,152,153,154,155],"Spine surgery","Postoperative pain management","Calcium sulfate beads","Vancomycin","Analgesics","Hospital length of stay","2026-04-14",{"date":158,"type":45},"2026-04-16",{"date":47,"type":21},{"date":161,"type":21},"2028-01-01",{"name":163,"class":52},"Ganesh M. Shankar",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":4},"100621788","ori-guided-fio-titration-in-prone-spine-surgery-impact-on-postoperative-atelectasis-assessed-by-lung-ultrasound-100621788","NCT07375173","ORI-Guided FiO₂ Titration in Prone Spine Surgery: Impact on Postoperative Atelectasis Assessed by Lung Ultrasound","Oxygen Reserve Index-Guided FiO₂ Titration in Prone Spine Surgery: Impact on Postoperative Atelectasis Assessed by Lung Ultrasound","Inclusion Criteria:\n\n1. Adults aged 18 to 80 years\n2. Patients with an ASA physical status of I, II, or III\n3. Individuals with a body mass index (BMI) between 18 and 35 kg\u002Fm²\n\nExclusion Criteria:\n\n1. History of or active upper or lower respiratory tract infection within the past month\n2. Pulmonary emphysematous\u002Fbullous disease or COPD\n3. Pre-existing significant atelectasis or consolidation (Preoperative LUS showing a score of 3 consolidation or ≥2 regions with a score ≥2)\n4. Severe obstructive sleep apnea requiring CPAP therapy\n5. NYHA class III-IV heart failure, EF \\\u003C35%, or severe valvular disease\n6. Severe arrhythmia or hemodynamic instability requiring high-dose vasopressors\n7. Body mass index (BMI) \\>35 kg\u002Fm²\n8. Severe anemia (Hb \\\u003C9 g\u002FdL) or polycythemia (Hb \\>18 g\u002FdL)\n9. Non-diagnostic or unclear preoperative lung ultrasound images\n10. Preoperative SpO₂ ≤ 94%\n11. Inability to apply the sensor due to finger deformity, or inadequate signal caused by digital hypoperfusion","80 Years",{"count":173,"type":21},74,[66],"Atelectasis is a frequent pulmonary complication after general anesthesia, often triggered by preoxygenation and intraoperative hyperoxia. High inspiratory oxygen fractions (FiO₂) can promote absorption atelectasis, ventilation-perfusion mismatch, hemodynamic alterations, and oxidative injury.\n\nThis study evaluates the effect of two intraoperative oxygen management strategies-oxygen reserve index (ORI)-guided FiO₂ titration versus fixed 50% FiO₂-on postoperative atelectasis in patients undergoing thoracolumbar spine surgery under general anesthesia. Atelectasis severity will be assessed using lung ultrasonography (LUS), scored across 12 thoracic regions (0-3 per region, total 0-36), while respiratory function changes will be examined via preoperative and 24-hour postoperative spirometry (FVC, FEV₁, FEV₁\u002FFVC).\n\nBecause postoperative spirometry may be influenced by pain, Numeric Rating Scale (NRS) scores will be recorded to help distinguish true restrictive patterns from pain-limited respiratory effort.\n\nThe study aims to determine whether ORI-guided FiO₂ titration can reduce postoperative atelectasis and improve respiratory outcomes compared with a fixed FiO₂ approach.",[177,178,28,179,180],"Atelectases, Postoperative Pulmonary","Prone Position","Lung Ultrasound","Oxygen Reserve Index","2026-01-24",{"date":183,"type":45},"2026-01-29",{"date":185,"type":21},"2026-03-15",{"date":187,"type":21},"2026-11-30",{"name":189,"class":190},"Ankara Etlik City Hospital","OTHER_GOV",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":62,"minAge":119,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":213,"leadSponsor":215,"locationsCount":53},"100619426","oral-melatonin-versus-oral-pregabalin-on-postoperative-pain-and-anxiety-following-spine-surgery-100619426","NCT07344467","Oral Melatonin Versus Oral Pregabalin on Postoperative Pain and Anxiety Following Spine Surgery","Effect of Oral Melatonin Versus Oral Pregabalin on Postoperative Pain and Anxiety Following Spine Surgery: A Prospective, Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged 21-60 years old.\n* Both sexes.\n* Patients of American Society of Anesthesiologists (ASA) physical status I \\& II.\n* Undergoing elective spine surgery.\n\nExclusion Criteria:\n\n* Patient refusal.\n* History of allergic reactions to melatonin or pregabalin.\n* Patients with cardiovascular disease (ischemic heart disease, Heart Failure, Arrythmia, Heart Block).\n* Patients with kidney disease with (plasma creatinine level \\> 1.5mg\u002Fdl).\n* Patients with liver disease with (aspartate transaminase, alanine transaminase, and bilirubin levels more than twice the upper limit of normal).\n* Psychological and cognitive disorders; dementia; major depression.\n* Circadian rhythm disorders such as chronic fatigue syndrome and drowsiness.","60 Years",{"count":200,"type":21},105,[66],"This study aims to compare the efficacy of using Melatonin versus Pregabalin on postoperative pain and anxiety after spine surgeries.",[204,205,206,207,208,28],"Oral","Melatonin","Pregabalin","Postoperative Pain","Anxiety","2026-01-17",{"date":211,"type":45},"2026-01-21",{"date":209,"type":45},{"date":214,"type":21},"2027-06-01",{"name":216,"class":52},"Tanta University",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":53},"100576442","minimum-effective-dose-of-incisional-local-infiltration-betamethasone-for-the-prevention-of-pain-after-spinal-surgery-100576442","NCT06785350","Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery","Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery: a Randomised Controlled Trial","Inclusion Criteria:\n\nPatients scheduled for spine surgery under general anesthesia. Anticipated cervical, thoracic, and lumbar spine surgeries (within three level).\n\nPatients age 18-65 years. American Society of Anaesthesiologists Classification of I or II.\n\nExclusion Criteria:\n\nPatients refuse to participate. Patients who are allergic to ropivacaine, betamethasone and opioid, . Pateints who have been abusing drugs or alcohol. Patients who have abnormalities in kidney or liver function tests. BMI\\\u003C15kg\u002Fm2 or\\>35 kg\u002Fm2. Patient has a history of spinal surgery. Patient has peri-incisional infection. Patient has a history of stroke or other serious neurological disease. Patient has a history of diabetes and other metabolic disorders. Patient has a history of psychological disorders. Patient is on systemic steroids. Patient is pregnant or breastfeeding. Glasgow Coma Scale score \\\u003C 15 before surgery. Unable to provide written informed consent.\n\nWithdrawal criteria:\n\nVoluntary withdrawal. Delayed extubation. Poor cognitive function within 48 hours after surgery. Postoperative radiation therapy or chemotherapy during follow-up. Postoperative diagnosis of spinal cord or nerve root injury resulting in pain during follow-up.\n\nReoperation during follow-up.","65 Years",{"count":226,"type":21},535,[66],"Incisional pain is a common complication after surgery and is an important cause of delayed postoperative recovery, increased length of hospital stay, increased risk of wound infection and respiratory\u002Fcardiovascular complications, as well as an important medical, social, and economic problem. Prevention and treatment of postoperative incision pain remains challenging. Local Infiltration Anaesthesia (LIA) for surgical incisions with an anti-inflammatory and analgesic combination has been reported to be effective in reducing postoperative pain, but there is a gap in the research on the optimal concentration of anti-inflammatory drugs in the anti-inflammatory and analgesic combination during local infiltration. The aim of this study was to investigate the optimal concentration of anti-inflammatory drugs in the anti-inflammatory-analgesic combination solution used for local infiltration of spinal surgical incisions to prevent postoperative pain.",[230,28],"Pain Management","2025-07-11",{"date":233,"type":45},"2025-07-16",{"date":235,"type":45},"2025-01-25",{"date":237,"type":21},"2025-12-01",{"name":239,"class":52},"Beijing Tiantan Hospital",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":22,"phases":250,"briefSummary":251,"conditions":252,"keywords":258,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":271,"locationsCount":53},"100591026","phase-4-effect-of-magnesium-on-neuromonitoring-100591026","NCT06975072","Effect of Magnesium on Neuromonitoring","Pharmacokinetics and Impact of Magnesium Sulfate on Neuromonitoring in Spinal Surgery","MgNm","Inclusion Criteria:\n\nAdult patients (\\>18 years of age) undergoing open thoracolumbar fusion with planned neuromonitoring\n\nExclusion Criteria:\n\n1. Patients with a history of significant cardiac disease (LVEF \\\u003C35%, 2nd\u002F3rd-degree block without a pacemaker, or significant arrhythmia)\n2. Patients with kidney disease (GFR \\\u003C30), or hepatic dysfunction (history of cirrhosis)\n3. Allergy or sensitivity to magnesium\n4. Patient with neuromuscular disease such as myasthenia graves",{"count":249,"type":21},20,[24],"Intraoperative neurophysiologic monitoring (IONM) is commonly used during complex spinal surgery to monitor the integrity of neural structures and improve the perioperative safety profile. Transcranial Motor Evoked Potentials (TcMEPs) monitor the integrity of the motor pathways and are one of the most commonly used monitoring modalities in spinal surgery. Because inhaled anesthetics can negatively affect the ability to monitor TcMEPs, anesthesiologists commonly use a combination of propofol and opioids to maintain the anesthetic state. Additionally, anesthesiologists will frequently administer intravenous infusions of medications that can decrease postoperative pain and opioid use (called opioid-sparing adjuncts) because spinal surgeries result in significant postoperative pain. Despite the increasing use of these agents, there is scant clinical data about how they may affect the integrity of TcMEP monitoring. Magnesium (Mg), a N-methyl-d-aspartate receptors (NMDA) receptor antagonist, is one of the adjuncts with robust data supporting clinical efficacy to decrease pain and opioid use on TcMEPs. Mg has been used clinically for decades. The investigators commonly utilize intravenous magnesium as a component of our spinal anesthesia protocol. However, there is only a single case report that discusses the effects of Mg on TcMEPs. Here the investigators propose a prospective clinical trial to quantitatively assess the effects of various Mg plasma levels on TcMEPs. There is a lack of literature on the pharmacokinetics of magnesium in non-pregnant patients.",[253,254,28,255,256,257],"Spine","Pain","Spine Surgery With Neuromonitoring","Spine Surgery With Motor Evoked Potential Monitoring","Spine Fusion",[259,260,261,262,263,264],"spine","spine surgery","spine fusion","magnesium","neuromonitoring","motor evoked potential monitoring","2025-07-02",{"date":267,"type":45},"2025-07-08",{"date":269,"type":45},"2025-07-01",{"date":129,"type":21},{"name":272,"class":52},"University of California, San Francisco",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":53},"100549891","irrisept-solution-for-instrumented-spine-surgery-100549891","NCT06439953","Irrisept Solution for Instrumented Spine Surgery","Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation","Inclusion Criteria:\n\n* Age: 18+ years old\n* Indications: deformity, oncologic, degenerative, trauma\n* Standard layer-by-layer closure\n* Locoregional flap-based closure\n\nExclusion Criteria:\n\n* Acute\u002Fchronic open wounds (spine or non-spine)\n* On-going non-spinal infection within 30 days of index operation\n* Concurrent antibiotic use (for spine or non-spine infections)\n* History of prior spinal infection\n* Allergy to vancomycin or chlorhexidine\n* Suspicion for osteomyelitis\n* Other surgery within 90 days post-operatively fromm index\n* Concurrent enrollment in other trial",{"count":281,"type":21},200,[66],"Various spine surgeons perform wound irrigation using saline mixed with vancomycin, relying on mechanical debridement of non-viable tissue, physical disruption of biofilm, and bacteriostatic effect against gram positive flora. When used as a powder, topical application of vancomycin has demonstrated increased risk of symptomatic seroma formation, which is an adverse outcome that often requires bedside or intra-operative aspiration. Broad-spectrum antiseptic agents, such as Irrisept, offer bacteriocidal properties to eliminate hardware inoculation, thereby minimizing the risk of deep space infection, while obviating the risk of seroma development.",[285,28,286,287,288,289,290,291],"Post-Op Complication","Site Infection","Surgical Site Infection","Spinal Instrumentation","Index Spinal Instrumentation","Layer-by-Layer Closure","Locoregional Flap-Based Closure","2024-11-18",{"date":294,"type":45},"2024-11-20",{"date":296,"type":45},"2024-10-01",{"date":298,"type":21},"2026-09-30",{"name":300,"class":52},"Rhode Island Hospital"]