Dexmedetomidine and Propofol for Sedation in Cataract Surgery.

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Ramsay sedation scale during surgery [Срок оценки: through study completion, an average of 1 year]
• Ramsay sedation scale in the recovery room [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Adults undergoing cataract surgery

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Ливан · 1 центр

• Hotel-Dieu de France — Beirut

Идентификаторы

NCT: NCT07556133 · CEHDF-2688

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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