Intranasal dexmedetomidine to stabilize blood pressure during cataract surgery in older adults
The Effect of Intranasal Dexmedetomidine Compared to Placebo on Blood Pressure in Elderly Hypertensive Patients Undergoing Cataract Surgery: A Double-Blind Randomized Controlled Trial
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 |
| Enrollment | 126 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Suez Canal University Academic / other |
| Locations | 1 site (Ismailia, Ismailia Governorate) |
| Trial ID | NCT07080229 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ismailia, Ismailia Governorate
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.