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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults undergoing cataract surgery

Locations
Other Locations
Lebanon
Hotel-Dieu de France
RECRUITING
Beirut
Contact Information
Primary
Rhea Nacouzi, MD
rhea.nacouzi@net.usj.edu.lb
+961 3359528
Time Frame
Start Date: 2025-11-09
Estimated Completion Date: 2026-12-09
Participants
Target number of participants: 1000
Treatments
Active_comparator: Dexmedetomidine-fentanyl DEX-FEN
DEX-FEN group: received dexmedetomidine (loading dose 0.5 µg/kg over 10 minutes, followed by maintenance at 0.25µg/kg/h) and a single fentanyl bolus (1 µg/kg).
Active_comparator: Propofol-Fentanyl PRO-FEN
PRO-FEN group: received propofol (target-controlled infusion to achieve a Ramsay Sedation Score of 2-3 as much as possible) and a single fentanyl bolus (1 µg/kg).
Active_comparator: DEX-PRO-FEN
DEX-PRO-FEN : received dexmedetomidine (loading dose 0.5 µg/kg over 10 minutes, followed by maintenance at 0.25µg/kg/h), propofol (target-controlled infusion to achieve a Ramsay Sedation Score of 2-3 as much as possible), with a single fentanyl bolus (1 µg/kg).
Sponsors
Leads: Saint-Joseph University

This content was sourced from clinicaltrials.gov

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