Effect of Different Administration Routes of Dexmedetomidine Combined with Ultrasound-Guided Fascia Iliaca Block on Emergence Agitation After Hip Replacement Surgery

Обзор

To examine the impact of various administration routes of dexmedetomidine in conjunction with ultrasound-guided fascia iliaca block (FIB) on emergence agitation (EA) during the postoperative recovery period after hip replacement surgery.

Вмешательства

• Препарат Dexmedetomidine Injection
  Before anesthesia induction, an iliac fascia block was administered using 0.375% ropivacaine (30 mL) under ultrasound guidance, followed by conventional anesthesia induction. During the anesthesia maintenance phase, dexmedetomidine was infused intravenously at a rate of 0.5 µg/kg/h.
• Препарат Ropivacaine and Dexmedetomidine
  Before anesthesia induction, an iliac fascia block was administered using a mixture of 0.375% ropivacaine and 1ug/kg dexmedetomidine (30ml) under ultrasound guidance. During the anesthesia maintenance phase, an equivalent volume of 0.9% sodium chloride injection was infused intravenously.
• Препарат Sodium Chloride Injection
  Before anesthesia induction, an iliac fascia block was performed using 0.375% ropivacaine (30 mL) under ultrasound guidance, followed by conventional anesthesia induction. During the anesthesia maintenance phase, an equivalent volume of 0.9% sodium chloride injection was infused intravenously.

Первичные конечные точки

• Incidence of awakening agitation [Срок оценки: postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU]

Вторичные конечные точки (4)

• Analgesic effect [Срок оценки: postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU]
• Ramesay score [Срок оценки: postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU]
• Hemodynamic parameters [Срок оценки: During operation]
• Record of laryngeal mask removal time and adverse reactions [Срок оценки: Within 24 hours after surgery]

Критерии участия

Критерии включения

• age between 18 and 65 years, with no restriction on gender
• diagnosis of hip joint disease necessitating hip arthroplasty
• ASA grade I-II
• no significant cardiopulmonary, hepatic, or renal dysfunction prior to the operation
• no history of psychiatric disorders or long-term use of sedative medications prior to the operation
• signing of an informed consent form to voluntarily participate in the study.

Критерии исключения

• patients allergic to or with contraindications to ropivacaine or dexmedetomidine
• patients exhibiting symptoms of agitation or delirium prior to the procedure
• patients with severe central or peripheral nervous system disorders
• patients with coagulation disorders or receiving anticoagulant therapy
• pregnant or breastfeeding women
• patients who received other medications or treatments prior to the procedure that might affect the study results
• patients unable to cooperate with the study or intolerant to ultrasound-guided iliofascial block

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

Лечение

Центры проведения

Китай · 1 центр

• Qianfoshan Hospital — Цзинань

Идентификаторы

NCT: NCT06614010 · LI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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