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Dexmedetomidine and Propofol for Sedation in Cataract Surgery.

ConditionsSedationCataractHemodynamicHemodynamic ChangesDexmedetomidinePropofol DosageFentanylBradycardiaTachycardiaNausea and Vomiting
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaint-Joseph University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults undergoing cataract surgery

Disqualifiers

Severe hepatic insufficiency

Third degree AV block

Patient refusal

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Dexmedetomidine-fentanyl DEX-FENActive comparator 2 interventions
Group B: Propofol-Fentanyl PRO-FENActive comparator 2 interventions
Group C: DEX-PRO-FENActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
through study completion, an average of 1 year
2

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.

Time frame
through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saint-Joseph University

Lead sponsor

Source ClinicalTrials.gov
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