Intranasal dexmedetomidine to stabilize blood pressure during cataract surgery in older adults
Official title: The Effect of Intranasal Dexmedetomidine Compared to Placebo on Blood Pressure in Elderly Hypertensive Patients Undergoing Cataract Surgery: A Double-Blind Randomized Controlled Trial
Run by Suez Canal University · NCT07080229 · Data updated 2026-11-12
This trial will test whether a single intranasal dose of dexmedetomidine given before cataract surgery helps control blood pressure in people aged 65 and older with hypertension.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 126 (estimated) |
| Sponsor | Suez Canal University Academic / other |
| Locations | 1 site (Ismailia, Ismailia Governorate) |
| Status | Recruiting |
| Started | July 16, 2025 |
| Main results expected | April 2026 |
| Study ends | May 2026 |
| Registry record updated | April 7, 2026 |
| Trial ID | NCT07080229 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 65 or older with stage 2 hypertension who are scheduled for elective cataract surgery under local anesthesia and classified as ASA II or III.
✕Probably not a fit
Patients with significant baseline bradycardia (<50 bpm), arrhythmias, allergy to dexmedetomidine, current sedative/anxiolytic use, or severe hepatic, renal, or cerebrovascular disease are excluded and may not receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 interventional trial compares intranasal dexmedetomidine (1 mcg/kg ideal body weight, diluted to 1 mL and delivered with a mucosal atomization device, 0.5 mL per nostril) to matching intranasal saline given before peribulbar anesthesia for elective cataract surgery. A peribulbar block using lidocaine 2% and bupivacaine 0.5% is used for local anesthesia in all patients. The primary outcome is perioperative mean arterial pressure (MAP) with secondary outcomes including sedation quality and adverse events. Eligible participants are adults aged 65 or older with stage 2 hypertension and ASA physical status II or III.
Why it matters
Potential benefit: If successful, the approach could reduce perioperative blood pressure swings and lower the risk of cardiovascular complications while providing gentle sedation for older patients.
How similar studies have gone: Prior smaller studies have shown intranasal dexmedetomidine can provide sedation and help stabilize hemodynamics, but robust phase 3 evidence in elderly hypertensive cataract patients is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged ≥65 years. 2. Patients who will have stage 2 hypertension as per ACC/AHA guidelines (Systolic BP \> 140 and Diastolic BP\> 90 mmHg) 3. Elective cataract surgery under local anesthesia. 4. American Society of Anesthesiologists (ASA) physical status II or III. Exclusion Criteria: 1. Allergy or contraindication to dexmedetomidine. 2. Significant baseline bradycardia (\<50 bpm) or arrhythmias. 3. Use of sedative or anxiolytic medications. 4. History of severe hepatic, renal, or cerebrovascular diseases.
Where it's running
-
Suez Canal University Hospitals
Ismailia, Ismailia Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Mohammad E Salama, MD
- Email: MohammadElhossieny88@med.suez.edu.eg
- Phone: +201016865861
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.