[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657948":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":28,"studyPopulation":18,"armGroups":29,"interventions":46,"overallOfficials":18,"centralContacts":57,"locations":18,"responsibleParty":63,"collaborators":18,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":18,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":91,"whyStopped":18,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":18},{"fullName":5,"class":6},"Zagazig University","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Quality of Recovery-40 score measured at 24 hours postoperatively","Quality of Recovery-40 contains 40 questions grouped into 5 dimensions:\n\n1. Physical Comfort (12 items)\n2. Emotional State (9 items)\n3. Physical Independence (5 items)\n4. Psychological Support (7 items) Scoring\n\nEach item is scored on a 5-point Likert scale:\n\n1. = None of the time\n2. = Some of the time\n3. = Usually\n4. = Most of the time\n5. = All of the time Total score range: 40-200\n\n   * 150-200 --- excellent recovery\n   * 140-159 --- good recovery\n   * Less than 140 --- moderate recovery","24 hours postoperatively",[14],{"measure":15,"description":16,"timeFrame":17},"visual analogue scale","pain intensity using visual analogue score after surgery by scale from 0 to 10 which 0 mean no pain and 10 mean maximium pain intensity","at 2,4,6,8,12,24,48 hours after surgery",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":24,"maskingDescription":18,"whoMasked":25},"DOUBLE",[26,27],"PARTICIPANT","CARE_PROVIDER","QoR -40 Questioner:\n\nThe QoR-40 contains 40 questions grouped into 5 dimensions:\n\n1\\. Physical Comfort (12 items)\n\n1. Able to breathe easily\n2. Have had good sleep\n3. Have felt comfortable\n4. Have had a good appetite\n5. Able to enjoy food\n6. No nausea\n7. No vomiting\n8. Feeling rested\n9. Feeling warm and comfortable\n10. No shivering\n11. No sweating\n12. Have had good general comfort\n\n2\\. Emotional State (9 items) 13. Been able to feel relaxed 14. Been in control 15. Been able to enjoy company of others. 16. Felt anxious 17. Felt angry or irritable 18. Felt depressed 19. Felt lonely 20. Felt confused 21. Felt frightened 3. Physical Independence (5 items) 22. Able to look after personal toilet and hygiene unaided 23. Able to write (or use your phone) 24. Able to speak normally 25. Able to wash yourself 26. Able to dress yourself 4. Psychological Support (7 items) 27. Able to communicate with family or friends 28. Able to communicate with hospital staff 29. Feeling supported by hospital staff 30. Feeling understood by others 31. Feeling supported by family or friends 32. Feeling able to share worries or concerns 33. Feeling encouraged by others 5. Pain (7 items) 34. Moderate pain 35. Severe pain 36. Headache 37. Muscle pains 38. Back pain 39. Sore throat 40. Pain affecting sleep\n\nScoring\n\nEach item is scored on a 5-point Likert scale:\n\n1. = None of the time\n2. = Some of the time\n3. = Usually\n4. = Most of the time\n5. = All of the time Total score range: 40-200\n\n   * 150-200 --- excellent recovery\n   * 140-159 --- good recovery\n   * Less than 140 --- moderate recovery",[30,36,41],{"label":31,"type":32,"description":33,"interventionNames":34},"Group (L) LIDOCAINE","ACTIVE_COMPARATOR","the patient will receive lidocaine IV infusion, loading dose (1.5 mg) diluted in 10 cm 0.9% saline given bolus then (1.5-2 mg\u002Fkg\u002Fh) will start after induction of anesthesia until the end of surgery.",[35],"Drug: Group ( L): LICOCAINE",{"label":37,"type":32,"description":38,"interventionNames":39},"Group (D)","the patient will receive Dexmedetomidine IV infusion, loading dose (0.5 -1 mcg\u002Fkg) diluted in 10 cm 0.9% saline given bolus then (0.2-0.7mcg\u002Fkg\u002Fh) will start after induction of anesthesia until the end of surgery.",[40],"Drug: GROUP Dexmedetomidine",{"label":42,"type":32,"description":43,"interventionNames":44},"Group (M)","the patient will receive Magnesium sulphate IV infusion, loading dose (30 mg\u002Fkg diluted in 10 cm 0.9% saline over 10-30 min than 6-20 mg\u002Fkg\u002Fh) will start after induction of anesthesia until the end of surgery.",[45],"Drug: Group M: Magnesium sulphate",[47,51,54],{"type":48,"name":49,"description":33,"armGroupLabels":50,"otherNames":18},"DRUG","Group ( L): LICOCAINE",[31],{"type":48,"name":52,"description":38,"armGroupLabels":53,"otherNames":18},"GROUP Dexmedetomidine",[37],{"type":48,"name":55,"description":43,"armGroupLabels":56,"otherNames":18},"Group M: Magnesium sulphate",[42],[58],{"name":59,"role":60,"phone":61,"phoneExt":18,"email":62},"asmaa mohammed galal el din, associative professor","CONTACT","01271550089","asmaa.galal79@gmail.com",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Asmaa Mohammed Galal El-Deen","Associative professor","100657948","intraoperative-infusion-of-dexmedetomidine-versus-lidocaine-or-magnesium-sulphate-for-enhanced-quality-of-recovery-after-spine-surgery-fixation-100657948",false,"NCT07843953","Intraoperative Infusion of Dexmedetomidine Versus Lidocaine or Magnesium Sulphate for Enhanced Quality of Recovery After Spine Surgery Fixation","Inclusion Criteria:\n\n1. Patient acceptance.\n2. Patients age between 18-60 years old.\n\n2- Both sexes. 3- Physical status from ASA I to III. 4- BMI ≥ 18 kg\u002Fm2 \\& ≤ 35 kg\u002Fm2. 5- Patient acceptance with written consent. 6- Elective lumbar fixation double level surgery\n\nExclusion Criteria:\n\n1. Uncooperative patient.\n2. Allergy to study drugs.\n3. Patients on chronic alcohol, opioid, tranquilizer or sedative use.\n4. Pregnancy.\n5. Emergency surgery",true,"ALL","18 Years","60 Years",{"count":78,"type":79},117,"ESTIMATED","INTERVENTIONAL",[82],"NA","Thoracolumbar fixation is a major spine surgery; it is performed to stabilize the spine after trauma, deformity or advanced degenerative disease. The primary surgical goals are to restore spinal alignment and achieve solid arthrodesis (fusion). From a surgical view, success is often measured by radiographic outcomes, hardware integrity and fusion rates. As anesthesiologists, we must recognize that technical success does not the same as optimal patient recovery.\n\nThis is why the concept of Quality of Recovery (QoR) becomes very important. QoR is a patient-centered outcome that covers more than the absence of surgical complications. It includes rapid return of physical function, pain control, psychological well-being, emotional stability and Patient satisfaction.\n\nTherefore, our focus in the perioperative care shifts the focus from \"did the surgery succeed?\" to \"how we can help the patient to recover physically, mentally, and functionally?\" This approach is measured using patient-reported outcomes such as the QoR-15 or QoR-40 questionnaires.\n\nDexmedetomidine (Precedex) has become one of the most valuable medications in modern anesthesia, especially for surgeries associated with significant pain. As a highly selective α2-adrenergic agonist, dexmedetomidine provides a unique combination of analgesia, anxiolysis, and cooperative sedation without causing respiratory depression; it is helpful during painful procedures such as spine surgery.\n\nWhen infused intraoperative; Precedex reduces central sensitization and diminishes the stress response to surgical stimuli, resulting in improved intraoperative hemodynamic stability, lower postoperative pain scores, reduced opioid requirements, and a smooth and calm recovery from anesthesia.\n\nIntraoperative intravenous lidocaine infusion has become an important tool for improving postoperative pain control; especially in major surgeries. Although lidocaine is commonly known as a local anesthetic, when given systemically during surgery it works in several meaningful ways: it calms the central nervous system, reduces the body's inflammatory response to tissue trauma, and decreases pain sensitivity that often appears after anesthesia wears off.\n\nBecause of these combined effects, patients who receive IV lidocaine typically experience lower postoperative pain scores and need less opioid medications; therefore, avoid many opioid-related side effects such as nausea, sedation and constipation.\n\nLidocaine infusion not only reduces early postoperative pain but also help for faster recovery, earlier mobilization, and improved overall patient satisfaction.\n\nMagnesium sulfate has become an increasingly valuable tool for anesthesiologists caring for patients undergoing long and painful surgical procedures. During major surgeries, the body's stress response can increase pain and make anesthetic management more challenging.\n\nMagnesium works by blocking NMDA receptors, which are the key player in central sensitization and postoperative hyperalgesia. This means patients wake up with less pain, lower opioid requirements, and often more stable intraoperative vital signs. Many doctors preferred to use magnesium sulphate because it is inexpensive, widely available, and easy to administer as a slow infusion.",[85,86,87,88],"Opioid Free Anesthesia","Opioid Based Anesthesia","Spine Fixation Surgeries","Opiod-Related Disorders",[90],"Intraoperative Infusion of Dexmedetomidine versus Lidocaine or Magnesium Sulphate for Enhanced Quality of Recovery After, Spine Surgery Fixation","NOT_YET_RECRUITING","2026-09-21",{"date":94,"type":95},"2026-09-28","ACTUAL",{"date":97,"type":79},"2026-09-30",{"date":99,"type":79},"2027-01-01",{"name":5,"class":6}]