Opioid-Free Anesthesia and Pain Study in Cardiac Surgery Patients

Официальное название

Assessment od the Effects of Opioid-Free Anesthesia on Acute and Chronich Postsurgical Pain in Cardiac Surgery Patinets: A Prospective Randomized Controlled Trial

Обзор

The goal of this clinical trial is to compare the effect of opioid-free anesthesia on the intensity of acute and chronic postoperative pain in patients undergoing cardiac surgery. The study will also evaluate the safety of opioid-free anesthesia in this patient population. The main questions it aims to answer are: * Is opioid-free anesthesia effective in reducing the intensity of acute and chronic postoperative pain in cardiac surgery patients? * Is this anesthetic technique safe in this patient population? Patients will be randomized before surgery into two groups. In the first group, anesthesia will be performed with opioids, while in the second group, anesthesia will be performed without opioids. Researchers will measure acute postoperative pain during the first 48 hours using the Numeric Rating Pain Scale (NRPS). Chronic postoperative pain will be assessed after 3 months via a telephone interview. Additionally, the incidence of adverse events-including postoperative delirium (POD), hemodynamic instability, respiratory complications, constipation, and postoperative nausea and vomiting (PONV)-as well as overall treatment outcomes, will be evaluated.

Вмешательства

• Процедура Opioid Free Anaesthesia
  Anesthesia will consist of a multimodal combination of general non-opioid agents (propofol, dexmedetomidine, midazolam, sevoflurane, and esketamine) supplemented by regional anesthesia techniques, including the erector spinae plane block (ESPB), serratus anterior plane block, and parasternal block.
• Процедура Opioid Anesthesia
  This will include intraoperative opioids (e.g., fentanyl or sufentanil) in combination with general anesthetic agents such as propofol, sevoflurane, and midazolam, supplemented by additional analgesics as required. Regional anesthesia techniques (e.g., erector spinae plane block, serratus anterior plane block, or parasternal block) may also be performed at the discretion of the attending anesthesiologist

Первичные конечные точки

• Acute postoperativ pain [Срок оценки: Assessments will be performed upon extubation (T0) and then every 12 hours for the first 48 postoperative hours (at 12, 24, 36, and 48 hours).]
• Chronich postoperative pain [Срок оценки: Chronic postoperative pain will be assessed 3 months after cardiac surgery. Patients will be contacted by phone]

Вторичные конечные точки (1)

• Incidency of potsoperativ delirium [Срок оценки: Screening will begin after extubation and will be performed twice daily (once in the morning and once in the evening) for the first 5 postoperative days or until discharge from the hospital.]

Критерии участия

Критерии включения

• elective cardiac surgery patients

Критерии исключения

• Emergecy cardiac surgery patients

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

Открытое

Основная цель

Лечение

Центры проведения

Сербия · 1 центр

• Clinical Center of Serbia — Belgrade

Идентификаторы

NCT: NCT07618130 · 95/20

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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