Dexmedetomidine and Propofol for Sedation in Cataract Surgery.

Sponsor
Saint-Joseph University
Study ID
NCT07556133
Status
Recruiting
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Conditions

  • Bradycardia
  • Cataract
  • Dexmedetomidine
  • Fentanyl
  • Hemodynamic
  • Hemodynamic Changes
  • Nausea and Vomiting
  • Propofol Dosage
  • Sedation
  • Tachycardia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexmedetomidine (DEX) — DRUG
    Dexmedetomidine (loading dose 0.5 µg/kg over 10 minutes, followed by maintenance at 0.25µg/kg/h).
  • Propofol (PRO) — DRUG
    Propofol (target-controlled infusion to achieve a Ramsay Sedation Score of 2-3 as much as possible).
  • Fentanyl (FEN) — DRUG
    Single fentanyl bolus (1 µg/kg).

Study Details

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.

Key Dates

First listed
Apr 29, 2026
Start date
Nov 9, 2025
Status verified
Apr 2026
Primary completion
Nov 9, 2026
Completion
Dec 9, 2026

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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).

Primary Outcome Measure

Ramsay sedation scale during surgery [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

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