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RECRUITING
NCT07556133
NA

Dexmedetomidine and Propofol for Sedation in Cataract Surgery.

Sponsor: Saint-Joseph University

View on ClinicalTrials.gov

Summary

The goal of this prospective, randomized, single-blinded is to learn if there is an ideal sedation protocol in cataract surgery in adults. The main questions it aims to answer are: * Does the combination of Dexmedetomidine and Propofol affect significantly Ramsay sedation scale, compared to Dexmedetomidine and compared to Propofol? * How does each sedation protocol affect hemodynamics? (Heart rate and blood pressure) * Are respiratory events more common in a certain group? * Is the surgeon's satisfaction similar among groups? * Are adverse effects (bradycardia, hypotension, nausea) more common in a certain group? Researchers will compare 3 sedation protocols : Dexmedetomidine versus Propofol versus the combination of these 2 drugs and to see if one protocol is overall superior to the others. Fentanyl will also be used in all 3 sedation protocols. Participants will : * Receive one of these three protocols * Be operated for one or both eyes * Monitored during the whole surgery and in the recovery room * Be evaluated by the Ramsay sedation scale by a trained Anesthesiologist or CRNA during surgery and in the recovery room Surgeons will be asked about how much they were satisfied.

Official title: Dexmedetomidine vs Propofol for Sedation in Cataract Surgery : a Prospective Randomized Controlled Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2025-11-09

Completion Date

2026-12-09

Last Updated

2026-04-29

Healthy Volunteers

No

Interventions

DRUG

Dexmedetomidine (DEX)

Dexmedetomidine (loading dose 0.5 µg/kg over 10 minutes, followed by maintenance at 0.25µg/kg/h).

DRUG

Propofol (PRO)

Propofol (target-controlled infusion to achieve a Ramsay Sedation Score of 2-3 as much as possible).

DRUG

Fentanyl (FEN)

Single fentanyl bolus (1 µg/kg).

Locations (1)

Hotel-Dieu de France

Beirut, Lebanon