SedationNCT07556133
Dexmedetomidine and Propofol for Sedation in Cataract Surgery.
A study testing Dexmedetomidine (DEX), Propofol (PRO) and Fentanyl (FEN) in people with Sedation and Cataract, run by Saint-Joseph University at 1 site in Lebanon.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation, Cataract, Hemodynamic
- What is being tested?
- Dexmedetomidine (DEX), Propofol (PRO) and Fentanyl (FEN)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteLebanon
- Study dates
- 9 Nov 2025to 9 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults undergoing cataract surgery
Who cannot join
- Severe hepatic insufficiency
- Third degree AV block
- Patient refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site, 1 recruiting
- Recruiting
Hotel-Dieu de France
Beirut
Rhea Nacouzi, MD, +961 3359528, rhea.nacouzi@net.usj.edu.lb
About this study
Official title: Dexmedetomidine vs Propofol for Sedation in Cataract Surgery : a Prospective Randomized Controlled Trial.
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:
Read more
- 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.
Read the detailed description
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:
- 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).
- 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).
- DEX-PRO group: 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).
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.
- Conditions
- Sedation, Cataract, Hemodynamic, Hemodynamic Changes, Dexmedetomidine, Propofol Dosage
- Being tested
- Dexmedetomidine (DEX), Propofol (PRO), Fentanyl (FEN)
- Keywords
- Dexmedetomidine and propofol in cataract surgery, Cataract, sedation, Dexmedetomidine in cataract surgery, Sedation for cataract surgery
- Medical subject headings
- Cataract, Bradycardia, Tachycardia, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Dexmedetomidine-fentanyl DEX-FEN | Active comparator | 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). Receives: Drug: Dexmedetomidine (DEX); Drug: Fentanyl (FEN) |
| Propofol-Fentanyl PRO-FEN | Active comparator | 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). Receives: Drug: Propofol (PRO); Drug: Fentanyl (FEN) |
| DEX-PRO-FEN | Active comparator | 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). Receives: Drug: Dexmedetomidine (DEX); Drug: Propofol (PRO); Drug: Fentanyl (FEN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start9 Nov 2025
- Primary completion9 Nov 2026 (estimated)
- Study completion9 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hicham Abou Zeid, Saint-Joseph University
- Investigators
- Naji Abou Jalad, MD, Study director, Hotel Dieu de France Hospital, Beirut, Lebanon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556133
- Sponsor's protocol ID
- CEHDF-2688
- Status last verified
- Apr 2026
- First submitted
- 13 Dec 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No