Dexmedetomidine and Propofol for Sedation in Cataract Surgery.

NCT07556133 | Recruiting

• 1 other identifier: CEHDF-2688
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Dexmedetomidine and propofol in cataract surgery; Cataract; sedation; Dexmedetomidine in cataract surgery; Sedation for cataract surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  through study completion, an average of 1 year

Study Arms (3)

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).

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).

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).

Drug: Dexmedetomidine (DEX); Drug: Propofol (PRO); Drug: Fentanyl (FEN)

Interventions

Dexmedetomidine (DEX) DRUG

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

DEX-PRO-FEN; Dexmedetomidine-fentanyl DEX-FEN

Propofol (PRO) DRUG

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

DEX-PRO-FEN; Propofol-Fentanyl PRO-FEN

Fentanyl (FEN) DRUG

Single fentanyl bolus (1 µg/kg).

DEX-PRO-FEN; Dexmedetomidine-fentanyl DEX-FEN; Propofol-Fentanyl PRO-FEN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults undergoing cataract surgery

You may not qualify if:

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

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Hotel-Dieu de France

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Cataract; Bradycardia; Tachycardia; Nausea; Vomiting

Interventions

Dexmedetomidine; Propofol; Fentanyl

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines

Study Officials

• Naji Abou Jalad, MD

  Hotel Dieu de France Hospital, Beirut, Lebanon

  STUDY DIRECTOR

Central Study Contacts

Rhea Nacouzi, MD

CONTACT

+961 3359528; rhea.nacouzi@net.usj.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology and Critical Care

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: April 29, 2026
• Study Start: November 9, 2025
• Primary Completion (Estimated): November 9, 2026
• Study Completion (Estimated): December 9, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)