[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656072":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":44,"interventions":63,"overallOfficials":32,"centralContacts":77,"locations":83,"responsibleParty":99,"collaborators":32,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":32,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":32,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":131,"whyStopped":32,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Benha University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Optic Nerve Sheath Diameter","Optic nerve sheath diameter will be measured in millimeters using ultrasonography with a high-frequency linear probe placed gently over the closed upper eyelid. The measurement will be obtained 3 millimeters posterior to the globe.","Perioperative: baseline before induction; immediately after induction before laryngoscopy; immediately after intubation; 5 and 10 minutes after intubation.",[14,18,22,25,28],{"measure":15,"description":16,"timeFrame":17},"Heart Rate","Heart rate will be recorded to assess the hemodynamic response to induction of anesthesia and endotracheal intubation.","Perioperative: baseline before induction; immediately after induction before laryngoscopy; and 1, 5, and 10 minutes after intubation.",{"measure":19,"description":20,"timeFrame":21},"Mean Arterial Pressure","Mean arterial pressure will be recorded to assess changes in hemodynamic response associated with induction of anesthesia and endotracheal intubation.","Perioperative: baseline before induction of general anesthesia; immediately after completion of induction and before laryngoscopy; and 1, 5, and 10 minutes after endotracheal intubation.",{"measure":23,"description":24,"timeFrame":17},"Systolic Blood Pressure","Systolic blood pressure will be recorded to assess changes associated with induction of anesthesia and endotracheal intubation.",{"measure":26,"description":27,"timeFrame":17},"Diastolic Blood Pressure","Diastolic blood pressure will be recorded to assess changes associated with induction of anesthesia and endotracheal intubation.",{"measure":29,"description":30,"timeFrame":31},"Incidence of Intraoperative Hemodynamic Adverse Events","The number and percentage of participants experiencing any adverse event will be recorded.","Intraoperatively",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups receiving intravenous dexmedetomidine, intravenous lidocaine, or normal saline before induction of general anesthesia.","PREVENTION",{"masking":39,"maskingDescription":40,"whoMasked":41},"DOUBLE","Participants and the investigator responsible for data collection and outcome assessment will be blinded to group allocation. Study medications will be prepared by an independent anesthesiologist who will not participate in patient management, data collection, or outcome assessment.",[42,43],"PARTICIPANT","OUTCOMES_ASSESSOR",[45,51,57],{"label":46,"type":47,"description":48,"interventionNames":49},"Dexmedetomidine Group","EXPERIMENTAL","Participants will receive dexmedetomidine 1 microgram per kilogram intravenously, diluted in 100 milliliters of normal saline and administered over 10 minutes before induction of anesthesia.",[50],"Drug: Dexmedetomidine",{"label":52,"type":53,"description":54,"interventionNames":55},"Lidocaine Group","ACTIVE_COMPARATOR","Participants will receive lidocaine 1.5 milligrams per kilogram intravenously as a slow bolus 2-3 minutes before induction of anesthesia.",[56],"Drug: Lidocaine",{"label":58,"type":59,"description":60,"interventionNames":61},"Control Group","PLACEBO_COMPARATOR","Participants will receive normal saline placebo intravenously before induction of anesthesia, administered in a manner intended to maintain study blinding.",[62],"Drug: Normal Saline",[64,69,73],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":32},"DRUG","Dexmedetomidine","Dexmedetomidine will be administered intravenously at a dose of 1 microgram per kilogram over 10 minutes before induction of general anesthesia.",[46],{"type":65,"name":70,"description":71,"armGroupLabels":72,"otherNames":32},"Lidocaine","Lidocaine will be administered intravenously at a dose of 1.5 milligrams per kilogram as a slow bolus 2-3 minutes before induction of general anesthesia.",[52],{"type":65,"name":74,"description":75,"armGroupLabels":76,"otherNames":32},"Normal Saline","Normal saline will be administered intravenously as placebo before induction of general anesthesia in a manner intended to maintain study blinding.",[58],[78],{"name":79,"role":80,"phone":81,"phoneExt":32,"email":82},"Ahmed S Thabet, MSc","CONTACT","+965 553 09982","Drsalem2019@yahoo.com",[84],{"facility":85,"status":32,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Benha University Hospitals","Banhā","Qalyubia Governorate","13511","Egypt","EG",{"type":92,"coordinates":93},"Point",[94,95],31.1842,30.45977,{"lat":95,"lon":94},[98],{"name":79,"role":80,"phone":81,"phoneExt":32,"email":82},{"type":100,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Ahmed Salem Thabet","Resident of Anesthesia, Intensive Care and Pain Management","100656072","phase-4-dexmedetomidine-versus-lidocaine-for-optic-nerve-sheath-diameter-during-craniotomy-intubation-100656072",false,"NCT07820540","Dexmedetomidine Versus Lidocaine for Optic Nerve Sheath Diameter During Craniotomy Intubation","Effects of Intravenous Dexmedetomidine Versus Lidocaine on Optic Nerve Sheath Diameter During Endotracheal Intubation in Patients Undergoing Craniotomy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged 18 to 65 years\n* Male or female participants\n* American Society of Anesthesiologists physical status I to III\n* Scheduled for elective supratentorial craniotomy under general anesthesia\n\nExclusion Criteria:\n\n* Raised intraocular pressure\n* Pre-existing eye disease or ocular injury\n* Severe cardiac or pulmonary disease\n* Hepatic or renal impairment\n* Coagulopathy\n* Pregnancy\n* Known allergy to any of the study drugs\n* Difficult airway\n* Emergency craniotomy","ALL","18 Years","65 Years",{"count":114,"type":115},90,"ESTIMATED","INTERVENTIONAL",[118],"PHASE4","Endotracheal intubation during general anesthesia can cause temporary increases in heart rate, blood pressure, and intracranial pressure. These changes may be particularly important in patients undergoing craniotomy. Optic nerve sheath diameter, measured noninvasively using ultrasound, can be used as an indirect marker of changes in intracranial pressure.\n\nThis randomized controlled trial will compare intravenous dexmedetomidine, intravenous lidocaine, and normal saline in patients undergoing elective supratentorial craniotomy under general anesthesia. The study will evaluate whether dexmedetomidine or lidocaine can reduce changes in optic nerve sheath diameter associated with endotracheal intubation and improve hemodynamic stability compared with placebo.\n\nThe investigators hypothesize that dexmedetomidine and lidocaine will attenuate the increase in optic nerve sheath diameter and the hemodynamic response associated with endotracheal intubation.",[121],"Endotracheal Intubation",[123,124,125,126,66,70,127,128,129,130],"Optic nerve sheath diameter","Intracranial pressure","Endotracheal intubation","Craniotomy","Hemodynamic response","Neuroanesthesia","Ultrasonography","Supratentorial craniotomy","NOT_YET_RECRUITING","2026-09-14",{"date":134,"type":135},"2026-09-15","ACTUAL",{"date":137,"type":115},"2026-09-20",{"date":139,"type":115},"2027-06-15",{"name":5,"class":6},1]