drugset / Trial / NCT07556133

Dexmedetomidine and Propofol for Sedation in Cataract Surgery.

NCT07556133 ↗

Recruiting 1000 enrolled Saint-Joseph University
RandomizedParallel-groupSingle-blindOther

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.

Timeline

Start
2025-11-09
Primary completion
2026-11-09
Completion
2026-12-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 0.25 ug/kg —
Comparator Propofol Small molecule — —
Comparator Fentanyl Other / unclassified 1 ug/kg —