RecruitingNot ApplicableNCT07556133

Dexmedetomidine and Propofol for Sedation in Cataract Surgery.

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


Sponsor

Saint-Joseph University

Enrollment

1,000 participants

Start Date

Nov 9, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Adults undergoing cataract surgery

Exclusion Criteria3

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

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Interventions

DRUGDexmedetomidine (DEX)

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

DRUGPropofol (PRO)

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

DRUGFentanyl (FEN)

Single fentanyl bolus (1 µg/kg).


Locations(1)

Hotel-Dieu de France

Beirut, Lebanon

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NCT07556133


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