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NCT Number: NCT07556133

Dexmedetomidine and Propofol for Sedation in Cataract Surgery.

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.

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Key information

Conditions

Sedation Arrhythmias, Cardiac Bradycardia Cardiac Conduction System Disease Cardiovascular Diseases Cataract Dexmedetomidine Eye Diseases Fentanyl Heart Diseases Hemodynamic Hemodynamic Changes Lens Diseases Nausea Nausea and Vomiting Pathologic Processes Pathological Conditions, Signs and Symptoms Propofol Dosage Signs and Symptoms Signs and Symptoms, Digestive Tachycardia Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults undergoing cataract surgery

Exclusion criteria

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

Treatment and study plan

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).

Primary outcomes

  1. Ramsay sedation scale during surgery

    Time frame: through study completion, an average of 1 year

    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.

  2. Ramsay sedation scale in the recovery room

    Time frame: through study completion, an average of 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rhea Nacouzi, MD

CONTACT

[email protected]

+961 3359528

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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