Sedation with dexmedetomidine, propofol, or both during cataract surgery
Dexmedetomidine vs Propofol for Sedation in Cataract Surgery : a Prospective Randomized Controlled Trial.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saint-Joseph University Academic / other |
| Locations | 1 site (Beirut) |
| Trial ID | NCT07556133 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults undergoing cataract surgery Exclusion Criteria: * Severe hepatic insufficiency * Third degree AV block * Patient refusal
Where this trial is running
Beirut
- Hotel-Dieu de France — Beirut, Lebanon (Recruiting)
Study contacts
- Study coordinator: Rhea Nacouzi, MD
- Email: rhea.nacouzi@net.usj.edu.lb
- Phone: +961 3359528
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.