[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560950":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":32,"overallOfficials":13,"centralContacts":40,"locations":46,"responsibleParty":59,"collaborators":61,"id":65,"slug":13,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":13,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":13,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":13,"overallStatus":49,"whyStopped":13,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Egymedicalpedia","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Eye Movement","Incidence of patients who are not moving their Eyes during long eye surgery","from 0 hours to 4 hours after the procedure",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","DIAGNOSTIC",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","Ophthalmic surgery is a precise surgical procedure that requires absolute immobilization. Many ophthalmic procedures can be performed safely in an outpatient setting, using local anesthesia.\n\nPropofol is currently the most commonly used intravenous anesthetic. It has a rapid onset of action, a short half-life and is associated with rapid recovery of cognitive ability. However, propofol can lead to injection pain, propofol infusion syndrome, and hemodynamic and respiratory depression. Therefore, there is a need for new anesthetic drugs with high efficacy and fewer side effects while providing stable and controllable anesthesia.\n\nRemifentanil is a short-acting esterase metabolized opioid with analgesic and sedative effects. Its half-life is about 5-10 min so that it can be titrated closely in response to changes in intraoperative requirements and with a low risk of accumulation.\n\nRemimazolam is a novel ultrashort-acting benzodiazepine agonist that works on γ-aminobutyric acid type A (GABA-A) receptors to reduce neuronal excitation and thereby achieve hypoactivity and sedation in the body. Remimazolam is metabolized by a nonspecific esterase, and the metabolite has no pharmacological effect, which allows prolonged infusion without accumulation.\n\nIt provides rapid anesthesia and arousal while stabilizing hemodynamics and produces less depression of respiration, making it more suitable for use in elderly and hemodynamically unstable patients.",[22,28],{"label":23,"type":24,"description":25,"interventionNames":26},"Group A: Remifentanil Group","ACTIVE_COMPARATOR","About 35 Patients will receive Remifentanil bolus of 1 μg\u002Fkg over 30 seconds followed by a continuous infusion of 0.03-0.05 μg\u002Fkg\u002Fmin.",[27],"Drug: Remifentanil",{"label":29,"type":24,"description":30,"interventionNames":31},"Group B: Remimazolam Group","About 35 Patients will receive remimazolam bolus of 0.2mg\u002Fkg followed by a continuous infusion of 0.3-0.5 μg\u002Fkg\u002Fh.",[27],[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Remifentanil","to compare remifentanil and remimazolam to limit patient movement during long-eye surgeries under local anesthesia.",[23,29],[39],"emimazolam",[41],{"name":42,"role":43,"phone":44,"phoneExt":13,"email":45},"Ahmed M. Elnagar, M.D","CONTACT","+201007529357","Ahmed.elnaggar@azhar.edu.eg",[47],{"facility":48,"status":49,"city":50,"state":13,"zip":13,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":13},"Al-Azhar University hospitals","RECRUITING","Cairo","Egypt","EG",{"type":54,"coordinates":55},"Point",[56,57],31.24967,30.06263,{"lat":57,"lon":56},{"type":60,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[62],{"name":63,"class":64},"Al-Azhar University","OTHER","100560950",false,"NCT06583811","Remifentanil and Remimazolam to Limit Patient Movement","Remifentanil and Remimazolam to Limit Patient Movement During Long-Eye Surgeries Under Local Anesthesia","Inclusion Criteria:\n\n* Age \\> 40 years.\n* Both sexes.\n* American Society of Anesthesiology (ASA) physical status I-III.\n* Undergoing long-eye surgeries under local anesthesia using peribulbar block with an expected surgical time of more than one hour.\n\nExclusion Criteria:\n\n* Patients on aspirin or anticoagulants.\n* Allergy to any study medication.\n* Drug abuse.\n* Uncontrolled hypertension.\n* Hyperthyroidism.\n* Frequent cough.\n* Impaired hearing.\n* Severe liver and kidney dysfunction.\n* Neurological or psychological disorders.\n* Partial or failed block.","ALL","40 Years","50 Years",{"count":75,"type":76},70,"ESTIMATED","INTERVENTIONAL",[79],"NA","Local anesthetics (LA) may be administered by injection (retrobulbar, peribulbar, subconjunctival, lid, or facial block) or by instillation (topical anesthesia), Considerable drawbacks of local anesthesia in these patients include the fact that a few patients can remain comfortable on an operating table for procedures that exceed two or three hours.\n\nSedation may be helpful with LA to decrease the experience of discomfort, movement and anxiety, which may in turn positively influence hemodynamic parameters, patient satisfaction, and overall improve surgical safety. Sedatives used in eye surgeries include benzodiazepines, opioids, alpha-adrenoceptor agonists, and propofol.",[82],"Long-Eye Surgeries","2024-08-31",{"date":85,"type":86},"2024-09-04","ACTUAL",{"date":88,"type":86},"2024-07-10",{"date":90,"type":76},"2025-01-10",{"name":5,"class":6},1]