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Набор скоро начнётся NCT07169227

Lidocaine, Paracetamol, and Dexmedetomidine for Rocuronium Injection Pain

Фаза IV С лечением Propofol Injection Pain Rocuronium Injection Pain

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: Lidocaine %2 ampoule, Dexmedetomidine, paracetamol.
Кому может быть актуально
Состояния в реестре: Propofol Injection Pain, Rocuronium Injection Pain. Базовые параметры: 18 лет — 65 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Comparison of the Efficacy of Lidocaine, Paracetamol, and Dexmedetomidine in Preventing Rocuronium Injection Pain

Обзор

Propofol and rocuronium may cause pain during intravenous injection. Various pharmacological agents are used to reduce the incidence and severity of injection pain. Among the most commonly used agents for this purpose are lidocaine, various opioids, ketamine, paracetamol, and dexmedetomidine. The aim of this study was to evaluate the comparative effect of intravenous dexmedetomidine and paracetamol versus lidocaine in preventing propofol- and rocuronium-induced pain during anesthesia induction.

Подробное описание

General anesthesia induction is initiated with propofol, and after loss of consciousness is achieved, rocuronium is administered to provide muscle relaxation. Propofol and rocuronium may cause pain during intravenous injection, with an incidence ranging from 20% to 100% for propofol and from 22% to 84% for rocuronium. The current hypothesis regarding the mechanism of pain associated with intravenous drug injection is that stimulation of polymodal nociceptors triggers the release of endogenous pain mediators such as prostaglandins. This stimulation is thought to be related to the non-physiological osmolarity or pH of the drug solution.

The pain that occurs during anesthesia induction may lead to undesirable reflex movements, which can result in accidental dislodgement of the intravenous catheter. In addition, in response to strong nociceptive stimulation, it may also contribute to the development of increased arterial blood pressure and tachycardia. Various pharmacological and non-pharmacological strategies have been investigated to reduce the incidence and severity of injection pain. Among the most commonly used agents for this purpose are lidocaine, various opioids, magnesium, sodium bicarbonate, ketamine, paracetamol, and dexmedetomidine.

Although lidocaine is frequently used to prevent propofol/rocuronium injection pain during anesthesia, propofol or rocuronium pain can still occur in up to 30% of cases, even with lidocaine administration. Therefore, there is currently no pharmacological agent in the literature that has been definitively confirmed to reduce propofol/rocuronium pain.

Paracetamol is a widely used agent for pain management and as an antipyretic, although its precise molecular mechanism of action is not fully understood. However, the antinociceptive effects of paracetamol are thought to occur through both peripheral and central mechanisms via inhibition of cyclooxygenase-2 (COX-2). With its peripheral effects, paracetamol is thought to reduce propofol- and rocuronium-induced injection pain and the associated involuntary withdrawal movements . In addition, paracetamol has been shown to selectively suppress peripheral PGE₂ release and to increase COX-2 gene expression in an acute inflammation model. Another study reported that paracetamol exhibits selectivity in inhibiting the synthesis of prostaglandins and related factors. Furthermore, although paracetamol does not inhibit COX enzymes at therapeutic concentrations in vitro, it has been reported to inhibit a variant of COX enzymes in vivo.

Dexmedetomidine is an α₂-adrenergic receptor agonist with supraspinal, spinal, and peripheral effects, possessing strong sedative, analgesic, and sympatholytic properties. Alpha-2 receptors are found in blood vessels and inhibit the release of norepinephrine. Although some studies in the literature have reported that dexmedetomidine reduces propofol- and rocuronium-induced pain, there are also studies that do not support this finding. Moreover, the effective optimal dose of this agent has not yet been clearly established.

The aim of this study was to evaluate the comparative effect of intravenous dexmedetomidine and paracetamol versus lidocaine in preventing propofol- and rocuronium-induced pain during anesthesia induction.

The goal of this study is to identify an effective pharmacological agent to reduce propofol and rocuronium injection pain. This study is a prospective, randomised study involving 170 subjects and they will assessed on the incidence and severity of rocuronium and propofol pain during anesthesia induction. Outcomes from this study can be extended to patients who will be receiving general anaesthesia tube to reduce the incidence and severity of propofol and rocuronium injection pain.

Вмешательства

  • Препарат Lidocaine %2 ampoule
    Patients who were administered 40 mg lidocaine.
  • Препарат Dexmedetomidine
    Patients who were administered 0.25 mg/kg dexmedetomidine.
  • Препарат paracetamol
    Patients who were administered 50 mg paracetamol.

Первичные конечные точки

  • Rocuronium Withdrawal Movement Score [Срок оценки: Immediately after rocuronium injection]
Вторичные конечные точки (1)
  • Propofol Pain Score [Срок оценки: Immediately after propofol injection]

Критерии участия

Критерии включения

Patients who will receive propofol and rocuronium 18 - 65 years No psychiatric disorders Elective surgery Those who accept the research No history of allergy to any of the drugs used in the study Patients in American Society of Anesthesiologists (ASA) I and II class

Критерии исключения

Patients with chronic pain syndromes Patients with difficult intravenous access Patients with advanced heart block or heart failure Patients with uncontrolled hypertension (Systolic blood pressure >160 mmHg)

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

Turkey (Türkiye) · 1 центр
  • Baskent University — Adana

Публикации

  • Uzun S, Erden IA, Canbay O, Aypar U. The effect of intravenous paracetamol for the prevention of rocuronium injection pain. Kaohsiung J Med Sci. 2014 Nov;30(11):566-9. doi: 10.1016/j.kjms.2014.08.002. Epub 2014 Sep 22. PMID 25458046
  • He L, Xu JM, He T, Liu L, Zhu R. Dexmedetomidine pretreatment alleviates propofol injection pain. Ups J Med Sci. 2014 Nov;119(4):338-42. doi: 10.3109/03009734.2014.941049. Epub 2014 Oct 24. PMID 25342205
  • Kwak HJ, Kim JY, Kim YB, Min SK, Moon BK, Kim JY. Pharmacological prevention of rocuronium-induced injection pain or withdrawal movements: a meta-analysis. J Anesth. 2013 Oct;27(5):742-9. doi: 10.1007/s00540-013-1595-7. Epub 2013 Mar 22. PMID 23519582

Идентификаторы

NCT: NCT07169227 · KA25/209

Первоисточники (государственные реестры)

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