Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07556133

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults undergoing cataract surgery
Not Eligible

You will not qualify if you...

  • Severe hepatic insufficiency
  • Third degree AV block
  • Patient refusal

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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