Sedation with dexmedetomidine, propofol, or both during cataract surgery
Official title: Dexmedetomidine vs Propofol for Sedation in Cataract Surgery : a Prospective Randomized Controlled Trial.
Run by Saint-Joseph University · NCT07556133 · Data updated 2026-11-12
This project will test whether dexmedetomidine, propofol, or their combination (each given with fentanyl) provides the best sedation, safety, and surgeon satisfaction for adults having cataract surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Saint-Joseph University Academic / other |
| Locations | 1 site (Beirut) |
| Status | Recruiting |
| Started | November 9, 2025 |
| Main results expected | November 9, 2026 |
| Study ends | December 9, 2026 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT07556133 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults scheduled for elective cataract surgery who meet inclusion criteria and do not have contraindications such as severe hepatic insufficiency or third-degree AV block are ideal candidates.
✕Probably not a fit
Patients with severe hepatic failure, untreated third-degree AV block, those requiring general anesthesia, or those who decline the sedation protocol are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, single-blind trial that enrolls adults undergoing elective cataract surgery and assigns them to one of three sedation protocols: dexmedetomidine plus fentanyl, propofol plus fentanyl, or a combination of dexmedetomidine and propofol with fentanyl. Dosing includes a dexmedetomidine loading dose (0.5 µg/kg over 10 minutes) with maintenance infusion, target-controlled propofol to reach Ramsay Sedation Score 2–3, and a single fentanyl bolus (1 µg/kg) in all groups. Patients are continuously monitored intraoperatively for sedation level, heart rate, blood pressure, and respiratory events, and outcomes include surgeon satisfaction and adverse events such as bradycardia, hypotension, nausea, and respiratory complications. The study compares efficacy and safety across the three protocols to identify whether one approach offers superior balance of comfort and physiologic stability.
Why it matters
Potential benefit: If successful, the results could identify a sedation approach that provides comfortable, stable sedation with fewer cardiorespiratory side effects for patients having cataract surgery.
How similar studies have gone: Previous randomized comparisons of dexmedetomidine and propofol for procedural sedation have shown mixed results, and combining both agents with fentanyl in cataract surgery has been less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults undergoing cataract surgery Exclusion Criteria: * Severe hepatic insufficiency * Third degree AV block * Patient refusal
Where it's running
-
Hotel-Dieu de France
Beirut, Lebanon Recruiting
Study contacts
- Study coordinator: Rhea Nacouzi, MD
- Email: rhea.nacouzi@net.usj.edu.lb
- Phone: +961 3359528
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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.