Actively Recruiting
Dexmedetomidine vs Propofol for Sedation in Cataract Surgery: a Prospective Randomized Controlled Trial
Led by Saint-Joseph University · Updated on 2026-04-29
1000
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating sedation protocols for adults undergoing cataract surgery to find the best approach for patient comfort and safety. This study compares the effects of three sedation methods: dexmedetomidine combined with fentanyl, propofol combined with fentanyl, and a combination of dexmedetomidine, propofol, and fentanyl. The goal is to understand how these protocols impact sedation levels, heart rate, blood pressure, respiratory events, surgeon satisfaction, and side effects like bradycardia, hypotension, and nausea. Participants will be randomly assigned to one of three groups receiving different sedation treatments. The dexmedetomidine groups receive a loading dose followed by maintenance infusion, propofol is given via target-controlled infusion to reach a specific sedation level, and all groups receive a single bolus of fentanyl. Three anesthesiologists will administer the protocols during elective cataract surgery on one or both eyes, with monitoring throughout the procedure and recovery. During the study, trained anesthesiologists and nurse anesthetists will assess sedation using the Ramsay sedation scale during surgery and in recovery. Participants will be closely monitored for vital signs and adverse effects. Surgeons will share their satisfaction with the sedation. The main outcomes measured are sedation levels during surgery and recovery, tracked over approximately one year. Safety and comfort will be carefully observed throughout the study period.
CONDITIONS
Brief Title
Dexmedetomidine and Propofol for Sedation in Cataract Surgery.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults undergoing cataract surgery
You will not qualify if you...
- Severe hepatic insufficiency
- Third degree AV block
- Patient refusal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the surgery and immediate recovery period
Participants receive sedation with either dexmedetomidine-fentanyl, propofol-fentanyl, or dexmedetomidine-propofol-fentanyl during cataract surgery.
1 day with sedation administered during surgery and monitoring in the recovery room
Duration - Up to 1 year after surgery
Participants are monitored for sedation effects and recovery using the Ramsay sedation scale during surgery and in the recovery room, with follow-up assessments averaging up to 1 year.
Periodic follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Hotel-Dieu de France
Beirut, Lebanon
Actively Recruiting
Research Team
R
Rhea Nacouzi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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