Effect of Ketalar or Dexmedetomidine on Increased Sensitivity to Pain Following Treatment With Remifentanil

Официальное название

Comparison of the Effect of Ketalar or Dexmedetomidine on Increased Sensitivity to Pain Induced Following Treatment With Remifentanil in Patients Undergoing a Laparoscopic Cholecystectomy

Обзор

Analgesia is one of the pillars of anesthesia. One of the common opiates for pain relief, with a short half-life, is Remifentanil. However, following Remifentanil treatment an increased sensitivity to pain \[hyperalgesia\] appears. The aim of the study is to compare the effects between complementary treatments, like Ketalar and Dexmedetomidine, in preventing increased sensitivity to pain after Remifentanil treatment

Подробное описание

Analgesia is one of the pillars of anesthesia. For many years, opiates were the basic ingredient in pain relief. The effectiveness of these substances in pain relief caused them to be overused which resulted in a global epidemic of addiction, morbidity and mortality due to the overuse of these drugs. Some of the options for realizing a reduction in the use of opiates include the use of drugs with a more predictable pharmacological profile and a short half-life, such as Remifentanil. This opiate is stronger than Morphine and its half-life remains within a few minutes, without accumulation even after prolonged infusion. Therefore, it seems that the use of remifentanil is ideal, especially for prolonged anesthesia.

One of the severe complications following treatment with Remifentanil is the appearance of increased sensitivity to pain \[hyperalgesia\] which results from a central sensitivity to pain and is expressed by stimulation of sensory receptors for pain in the nervous system (nociceptive sensitization). In order to alleviate the feeling of pain following the increased sensitivity to pain after treatment with opiates, as well as with Remifentanil, complementary treatments, such as Ketalar and dexmedetomidine, were offered. This study will compare the ability of Ketalar or Dexmedetomidine in alleviating increased sensitivity to pain after treatment with Remifentanil in patients who are candidates for laparoscopic cholecystectomy.

Вмешательства

• Препарат Ketalar
  a dissociative anesthetic used medically for induction and maintenance of anesthesia
• Препарат Dexmedetomidine
  an agonist of α2-adrenergic receptors in certain parts of the brain used for sedation

Первичные конечные точки

• Pain Level [Срок оценки: Up to two hours after the end of the anesthesia process]
• Pain killer consumption [Срок оценки: Up to two hours after the end of the anesthesia process]

Критерии участия

Критерии включения

• Patients who are about to undergo alaparoscopic cholecystectomy under general anesthesia

Критерии исключения

• Patients with sensitivity to the anesthetic
• Patients with chronic pain who are in regular treatment
• Urgent surgery
• Patients with ischemic heart disease
• Patients with known bradycardia
• Patients with a pacemaker
• Prolonged use of opiates
• Kidney/liver function problems

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

Израиль · 1 центр

• Shamir (Asaf Harofe) Medical Center — Be’er Ya‘aqov

Идентификаторы

NCT: NCT06473896 · 0173-23-ASF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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