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Набор скоро начнётся NCT06684197

The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption

Без фазы С лечением Dexmedetomidine Total Intravenous Anesthesia Remifentanil Consumption Remifentanil

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dexmedetomidine, Placebo.
Кому может быть актуально
Состояния в реестре: Dexmedetomidine, Total Intravenous Anesthesia, Remifentanil Consumption, Remifentanil. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption: a Randomized Controlled Trial

Обзор

Opioids analgesic are the gold standard for intraoperative pain management. Their short- and long-term adverse effect motivate anesthesiologists to explore opioid sparing strategies. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that could help minimize opioid consumption both intraoperative and postoperative due to its sedative, analgesic and sympatholytic properties. This new randomized controlled trial (RCT) will answer the question whether an intraoperative dexmedetomidine infusion compared to placebo has a clinically significant impact on intraoperative remifentanil consumption during a laparoscopic abdominal elective surgery.

Подробное описание

Opioids analgesic have been used for intraoperative pain management for decades. They are the gold standard for pain relief due to their high efficacy. However, the short- and long-term adverse effects of opioids motivate anesthesia teams to explore opioid sparing strategies employing a combination of analgesics and adjuvants via continuous infusions. Opioid tolerance and opioid-induced hyperalgesia can lead to dose escalation of prescribed opioids and poor pain control.

Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that could help minimize opioid consumption both intraoperative and postoperative due to its sedative, analgesic and sympatholytic properties. Other post-procedure applications such as reduction of cough, agitation and shivering have been described.

Many trials have studied the impact of intraoperative dexmedetomidine on post-operative pain scores, post-operative opioids consumption and common side effects compared with a remifentanil intraoperative infusion. One randomized controlled trial studied the impact of a 30 min dexmedetomidine infusion on intraoperative remifentanil consumption in ASA 1-2 patients undergoing maxillofacial or cervicofacial surgeries. They found a clinically meaningful reduction of 33% of remifentanil consumption at 120 minutes in the dexmedetomidine group. This trial aims to demonstrate a similar reduction when extending to ASA 3 patients undergoing laparoscopic surgery. Furthermore, the investigators aim to evaluate patients' recovery and pain status 24h after the surgery which hasn't been done before in the context of joint dexmedetomidine and remifentanil infusion. The investigators hypothesize that patients of the dexmedetomidine infusion group will require less intraoperative remifentanil to keep the NOL-index into the prespecified range. In the PACU, lower pain score et less opioids requirements are anticipated.

Вмешательства

  • Препарат Dexmedetomidine
    Intravenous dexmedetomidine will be given as a bolus (0.5 μg.kg-1) over 10 minutes. A perfusion of 0.5 mcg.kg-1.h-1 of dexmedetomidine will be programmed and maintained up until the pneumoperitoneum is deflated or up until a total dose of 2.5μg.kg-1 has been administered.
  • Препарат Placebo
    Saline will be used instead of dexmedetomidine

Первичные конечные точки

  • Remifentanil consumption expressed in mcg.kg-1.h-1 [Срок оценки: From induction of anesthesia to end of surgery]
Вторичные конечные точки (12)
  • Total intraoperative propofol consumption (mg.kg-1.h-1) [Срок оценки: From induction of anesthesia to end of surgery]
  • Mean intraoperative blood pressure [Срок оценки: From induction of anesthesia to end of surgery]
  • Number of intraoperative episodes of high/low blood pressure [Срок оценки: From induction of anesthesia to end of surgery]
  • Number of episodes of intraoperative tachy-/bradycardia [Срок оценки: From induction of anesthesia to end of surgery]
  • Total intraoperative dose of vasopressors [Срок оценки: From induction of anesthesia to end of surgery]
  • intraoperative NOL index [Срок оценки: From intubation to end of surgery]
  • Time for extubation (in minutes) [Срок оценки: From end of surgery to extubation]
  • Morphine equivalent consumption in the post anesthesia care unit (PACU) [Срок оценки: From PACU admission to discharge from PACU (Aldrete Score >=9 / 10)]
  • Pain scores using visual analogue scale (VAS) in PACU [Срок оценки: From PACU admission to discharge from PACU (Aldrete Score >=9 / 10)]
  • Adverse events in PACU [Срок оценки: From PACU admission to discharge from PACU (Aldrete Score >=9 / 10)]
  • Lenght of stay in PACU (in minutes) [Срок оценки: From PACU admission to discharge]
  • Pain scores using numeric rating scale (NRS) 24h post-op [Срок оценки: post-op day 1]

Критерии участия

Критерии включения

  • ASA 1-3
  • Laparascopic surgery (including general surgery, gynecology, urology) a small abdominal incision (less than 5 cm) will be tolerated.

Критерии исключения

  • Patient refusal
  • Chronic use of opioids
  • Allergy to medication used in the trial
  • Pregnant or breastfeeding women
  • Contraindications to dexmedetomidine (Bradycardia, arrythmia or pace- maker, severe ventricular dysfunction)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Профилактика

Центры проведения

Канада · 1 центр
  • Hôpital Maisonneuve-Rosemont — Montreal

Публикации

  • Coeckelenbergh S, Doria S, Patricio D, Perrin L, Engelman E, Rodriguez A, Di Marco L, Van Obbergh L, Estebe JP, Barvais L, Kapessidou P. Effect of dexmedetomidine on Nociception Level Index-guided remifentanil antinociception: A randomised controlled trial. Eur J Anaesthesiol. 2021 May 1;38(5):524-533. doi: 10.1097/EJA.0000000000001402. PMID 33259449

Идентификаторы

NCT: NCT06684197 · CAR 2025-3856

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗