[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599110":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":61,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":26,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Suez Canal University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexmedetomidine group (Study group)","ACTIVE_COMPARATOR","In this group, Dexmedetomidine (1 mcg\u002Fkg ideal body weight) will be administered intranasally 30 minutes before surgery.",[13],"Drug: Intranasal dexmedetomidine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group (Control group)","PLACEBO_COMPARATOR","In this group, Normal Saline will be administered intranasally 30 minutes before surgery.",[19],"Drug: Intranasal normal saline",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Intranasal dexmedetomidine","Intranasal dexmedetomidine (1 mcg\u002Fkg ideal body weight) will be diluted to a total volume of 1 ml and will be administered via a mucosal atomization device (MAD) 30 minutes before surgery. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Intranasal normal saline","Intranasal normal saline (1 ml) will be administered via mucosal atomization device (MAD) 30 minutes before surgery. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Mohammad E Salama, MD","CONTACT","+201016865861","MohammadElhossieny88@med.suez.edu.eg",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Abdelrhman M Alshawadfy, MD","+201091091620","abdelrhmanalshawadfy@gmail.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Suez Canal University Hospitals","RECRUITING","Ismailia","Ismailia Governorate","41522","Egypt","EG",{"type":51,"coordinates":52},"Point",[53,54],32.27225,30.60427,{"lat":54,"lon":53},[57],{"name":58,"role":34,"phone":59,"phoneExt":26,"email":60},"Mahammad E Salama, MD","01016865861","mohammadelhossieny88@med.suez.edu.eg",{"type":62,"investigatorFullName":33,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Principal investigator","100599110","phase-3-intranasal-dexmedetomidine-on-blood-pressure-in-elderly-hypertensive-patients-undergoing-cataract-surgery-100599110",false,"NCT07080229","Intranasal Dexmedetomidine on Blood Pressure in Elderly Hypertensive Patients Undergoing Cataract Surgery","The Effect of Intranasal Dexmedetomidine Compared to Placebo on Blood Pressure in Elderly Hypertensive Patients Undergoing Cataract Surgery: A Double-Blind Randomized Controlled Trial","Inclusion Criteria:\n\n1. Patients aged ≥65 years.\n2. Patients who will have stage 2 hypertension as per ACC\u002FAHA guidelines (Systolic BP \\> 140 and Diastolic BP\\> 90 mmHg)\n3. Elective cataract surgery under local anesthesia.\n4. American Society of Anesthesiologists (ASA) physical status II or III.\n\nExclusion Criteria:\n\n1. Allergy or contraindication to dexmedetomidine.\n2. Significant baseline bradycardia (\\\u003C50 bpm) or arrhythmias.\n3. Use of sedative or anxiolytic medications.\n4. History of severe hepatic, renal, or cerebrovascular diseases.","ALL","65 Years",{"count":74,"type":75},126,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","Cataract surgery in elderly patients with controlled hypertension carries a risk of hemodynamic instability, particularly fluctuations in mean arterial blood pressure (MAP). Dexmedetomidine, a selective α2-adrenergic agonist, offers hemodynamic stabilization and sedation when administered intranasally and provides a simple and non-invasive premedication option.\n\nThis study evaluates the effects of intranasal dexmedetomidine on perioperative mean arterial blood pressure in patients undergoing cataract surgeries.\n\nResearch Question:\n\nDoes intranasal dexmedetomidine premedication control blood pressure in elderly hypertensive patients undergoing cataract surgery?\n\nResearch Hypothesis:\n\nIntranasal dexmedetomidine significantly reduces MAP and improves secondary outcomes compared to placebo.\n\nPrimary Objective: To evaluate the efficacy of intranasal Dexmedetomidine as a premedication to control hypertension in elderly patients scheduled for cataract surgery.\n\nSecondary Objectives: 1. To assess surgery cancellation rates. 2. To evaluate satisfaction levels among patients, anesthesiologists, and surgeons using the Modified Observer's assessment of alertness\u002Fsedation scale (MOAA\u002FS). 3- To evaluate the effect of intranasal dexmedetomidine on HR multiple readings starting from preoperative hold area till 2 hours postoperatively.\n\nThis randomized, double-blinded clinical trial will include 126 elderly hypertensive patients (≥65 years) undergoing cataract surgery under local anesthesia. Inclusion Criteria will consist of patients aged ≥65 years, ASA II or III, stage 2 hypertension as per ACC \u002F AHA guidelines (SBP\\>140 and DBP\\> 90 mmHg), undergoing elective cataract surgery under local anesthesia. Exclusion Criteria will include allergy or contraindication to dexmedetomidine, significant baseline bradycardia (\\\u003C50 bpm) or arrhythmia, use of sedative or anxiolytic medications, history of severe hepatic, renal, or cerebrovascular disease. Participants will be randomly assigned to receive either intranasal dexmedetomidine (1 mcg\u002Fkg ideal body weight) or a placebo (normal saline) 30 minutes before surgery. MAP, HR, and SpO₂ will be recorded at multiple perioperative intervals, and surgical cancellation rates, satisfaction levels will be noted, surgical duration, and hospital stay will be documented.",[81,82],"Cataract","Hypertension",[81,82,84,85],"Intranasal Dexmedetomidine","Elderly","2026-04-01",{"date":88,"type":89},"2026-04-07","ACTUAL",{"date":91,"type":89},"2025-07-16",{"date":93,"type":75},"2026-05",{"name":5,"class":6},1]