An interventional study of Dexmedetomidine (DEX) and Propofol (PRO) in Sedation, Cataract and Hemodynamic, sponsored by Saint-Joseph University. Recruiting at 1 site in Lebanon. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Saint-Joseph University · Not applicable, Interventional, and Other
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:
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 :
Cataract surgery is one of the most frequently performed procedures worldwide, particularly among elderly patients with multiple comorbidities. Although typically performed under regional or topical anesthesia, procedural sedation is often necessary to ensure patient comfort and immobility. The ideal sedative agent should offer adequate anxiolysis and analgesia with minimal cardiorespiratory depression and prompt recovery. Both dexmedetomidine and propofol are commonly used for procedural sedation; however, their comparative efficacy when combined with fentanyl and combined together in cataract surgery remains unclear. This study compares the efficacy, safety, and patient satisfaction between dexmedetomidine-fentanyl, propofol-fentanyl, and dexmedetomidine-propofol-fentanyl sedation.
In this prospective, randomized, single-blind study, patients undergoing elective cataract surgery were allocated to three groups:
Every patient is assigned randomly to a group. 3 different anesthesiologists will administer the protocol. The Ramsay score will be evaluated by the anesthesiologists themselves and a trained CRNA during the surgery and in the recovery room. The Ramsay score is explained in detail to the Anesthesiologist and CRNA in charge, with practical examples.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Saint-Joseph University is the lead sponsor of 71 studies on the registry; 11 are open to participants now.
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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).
Drug: Dexmedetomidine (DEX) · Drug: Fentanyl (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).
Drug: Propofol (PRO) · Drug: Fentanyl (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).
Drug: Dexmedetomidine (DEX) · Drug: Propofol (PRO) · Drug: Fentanyl (FEN)
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).
Single fentanyl bolus (1 µg/kg).
Ramsay sedation scale during surgery
The Ramsay Sedation Scale (RSS) is a 6-point tool used in medicine to assess a patient's level of sedation, from agitated (1) to deeply comatose (6), by evaluating their responsiveness to stimuli like voice and touch, helping clinicians achieve desired sedation levels.
Time frame: through study completion, an average of 1 year
Ramsay sedation scale in the recovery room
The Ramsay Sedation Scale (RSS) is a 6-point tool used in medicine to assess a patient's level of sedation, from agitated (1) to deeply comatose (6), by evaluating their responsiveness to stimuli like voice and touch, helping clinicians achieve desired sedation levels.
Time frame: through study completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.
Of 300 non-industry interventional studies with no phase under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 12 months is below that.
Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
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Studies of the drugs tested here: Dexmedetomidine · Propofol
Saint-Joseph University