Dexmedetomidine and Propofol for Sedation in Cataract Surgery.

April 21, 2026 updated by: Hicham Abou Zeid, Saint-Joseph University

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:

  • 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults undergoing cataract surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint-Joseph University

Investigators

  • Study Director: Naji Abou Jalad, MD, Hotel Dieu de France Hospital, Beirut, Lebanon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2025

Primary Completion (Estimated)

November 9, 2026

Study Completion (Estimated)

December 9, 2026

Study Registration Dates

First Submitted

December 13, 2025

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEHDF-2688

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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