Lidocaine Infusion Versus Magnesium Infusion in Decreasing Fentanyl Requirements in Endoscopic Sinus Surgeries

Официальное название

Evaluating the Effect of Lidocaine Infusion Versus Magnesium Sulfate Infusion on Decreasing Total Fentanyl Requirements in Patients Undergoing Functional Endoscopic Sinus Surgeries: a Randomized Controlled Study

Обзор

Enhanced recovery after ear, nose and throat surgery is based on multimodal and multidisciplinary perioperative interventions to decrease postoperative pain. Functional endoscopic sinus surgery is a surgical management for chronic rhinosinusitis. Although a common procedure, there is a lack of knowledge about perioperative pain and specific pain management after such a procedure. Most of recommendations given in guidelines for postoperative pain management in nasal surgery and sinus surgery are subsumed under head and neck surgery. Head and neck surgery is a wide field covering widely variable surgical procedures. So, postoperative pain management guidelines may not meet the requirements for pain management during and after endoscopic sinus surgery. Various medications have been used to improve the surgical field and postoperative pain including intravenous clonidine, dexmedetomidine, lidocaine, and magnesium. Lidocaine has been used considering its analgesic, immuno-modulating, and anti-inflammatory properties. The opioid sparing effect of lidocaine is supported by a high level of evidence. The effectiveness of lidocaine infusion in obtaining reduction of postoperative pain, gastrointestinal recovery time, postoperative nausea and vomiting, and shortening the hospital length of stay, was demonstrated principally in major gastro-intestinal surgery. Magnesium sulfate is a good option in multimodal analgesia, as it stabilizes the cell membrane and intracytoplasmic organelles by mediating the activation of Na+-K+ ATPase and Ca++ ATPase enzymes, which have an important role in transmembrane ion exchange during the depolarization and repolarization phases. Moreover, magnesium inhibits the release of norepinephrine by blocking the N-type Ca++ channels at nerve endings. Many studies were designed to prove the role of the analgesic effect of lidocaine and magnesium infusion. However, this is the first randomized controlled study to assess the effect of lidocaine infusion versus magnesium sulphate infusion on decreasing total fentanyl requirements in patients undergoing functional endoscopic sinus surgery. This randomized controlled trial was designed to compare the efficacy of lidocaine hydrochloride infusion versus magnesium sulphate infusion in controlling perioperative pain in patients undergoing functional endoscopic sinus surgery.

Вмешательства

• Препарат Lidocaine group
  25ml of lidocaine hydrochloride 2% will be added to 25 ml of standard saline 0.9% solution in a 50ml syringe to be infused via a syringe pump. The resultant concentration will be 10mg/ml. According to the calculated study drug dose, each patient will receive 0.2ml/kg/h
• Препарат Magnesium group
  a 50ml syringe will be filled with magnesium sulfate solution (100mg/ml) to be infused via a syringe pump. According to the calculated study drug dose, each patient will receive 0.2ml/kg/h
• Препарат Control group
  a 50ml syringe will be filled with a standard saline 0.9% solution to be infused via a syringe pump. Each patient will receive 0.2ml/kg/h

Первичные конечные точки

• intraoperative fentanyl consumption [Срок оценки: for 5 hours starting from induction of general anesthesia]

Вторичные конечные точки (4)

• intraoperative mean arterial blood pressure [Срок оценки: for 5 hours starting from induction of general anesthesia]
• Intraoperative heart rate [Срок оценки: for 5 hours starting from induction of general anesthesia]
• Clarity of the surgical field [Срок оценки: for 5 hours starting from induction of general anesthesia]
• Surgeon satisfaction [Срок оценки: for 5 hours starting from induction of general anesthesia]

Критерии участия

Критерии включения

• Age from 21 to 60 years.
• Both genders.
• American society of Anesthesiologist (ASA) physical status I-II
• Scheduled for functional endoscopic sinus surgery under general anesthesia.

Критерии исключения

• Patients with prolonged QT interval.
• Patients with renal disease.
• Patients with a history of allergy to lidocaine or magnesium sulfate.
• American Society of Anesthesiologists class higher than II.
• Patient refusal

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

Двойное слепое

Основная цель

Другое

Центры проведения

Египет · 1 центр

• Faculty of Medicine, Cairo University — Cairo

Идентификаторы

NCT: NCT06966102 · MS-15-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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