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Dexmedetomidine and Propofol for Sedation in Cataract Surgery.

NCT07556133 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-04-29

No results posted yet for this study

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
  • Propofol Dosage
  • Fentanyl
  • Bradycardia
  • Tachycardia
  • Nausea and Vomiting

Interventions

DRUG

Dexmedetomidine (DEX)

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

DRUG

Propofol (PRO)

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

DRUG

Fentanyl (FEN)

Single fentanyl bolus (1 µg/kg).

Sponsors & Collaborators

  • Saint-Joseph University

    lead OTHER

Principal Investigators

  • Naji Abou Jalad, MD · Hotel Dieu de France Hospital, Beirut, Lebanon

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-09
Primary Completion
2026-11-09
Completion
2026-12-09

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07556133 on ClinicalTrials.gov