Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery

Официальное название

The Effect of Intravenous Lidocaine or Ketamine on Interleukin-6 Levels in Patients Undergoing Colorectal Surgery for Cancer: A Randomized Controlled Trial

Обзор

Patients undergoing open colorectal surgery were randomly divided into two groups: Intravenous Lidocaine (IV-Lido) vs Intravenous Ketamine (IV-Keta). For the IV-Lido group, patients received a loading dose of Lidocaine than a continuous infusion over twenty-four hours. For the IV-Keta goup, patients received a loading dose of Ketamine than a continuous injection of Ketamine over twenty-four hours. Plasma concentrations of Interleukin-6(IL-6) were measured preoperatively before anesthetic induction and at twenty-four hour post operatively.

Подробное описание

Patients undergoing open colorectal surgery with tumor resection were randomised prospectively into two groups: Intravenous Lidocaine (IV-Lido) vs Intravenous Ketamine (IV-Keta).

For the IV-Lido group (n=25), patients received a loading dose of 1.5 mg/kg of Lidocaine than a continuous infusion of 1.5 mg/kg/h over twenty-four hours.

For the IV-Keta goup(n=25), patients received a loading dose of 0.15mg/kg of Ketamine than a continuous injection of 0.15 mg/kg/h of Ketamine over twenty-four hours.

For both groups, plasma concentrations of Interleukin-6(IL-6) were measured preoperatively before anesthetic induction and at twenty-four hour post operatively. Plasma IL-6 concentrations at each point were compared between the groups.

Вмешательства

• Препарат Lidocaine IV
  Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer
• Препарат Ketamine Injectable Solution
  Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer

Первичные конечные точки

• The variation of Interleukin-6 levels [Срок оценки: 24 hours after surgery]

Вторичные конечные точки (5)

• Pain assessed by Numerical Rating Scale (NRS) [Срок оценки: Postoperatively, at Hour 2, Hour 12 and Hour 24. the patient asked to circle the number between 0 and 10:"0" usually represents 'no pain at all' whereas "10" represents 'the worst pain ever possible'.]
• Post-operative nausea and vomiting [Срок оценки: During the first 24 hours postoperatively]
• Bowel function. [Срок оценки: During the first 24 hours postoperatively]
• Hospital length of stay. [Срок оценки: From date of randomization until the date of to discharge from the hospital assessed up to 15 days]
• Post-operative complications. [Срок оценки: From date of randomization until the date of to discharge from the hospital assessed up to 15 days]

Критерии участия

Критерии включения

• Patients aged 18 or older.
• American society of anesthesiologists' (ASA) physical status of I-III.
• Elective open colorectal surgery.

NON INCLUSION CRITERIA:

• Patients with contraindications to lidocaine or ketamine.
• Corticosteroid therapy within the last 6 months.
• History of immunosuppressive therapy.
• History of surgery in the last 3 months.
• Personal medical history of inflammatory bowel disease.
• Personal medical history of cardiac arrythmias or conduction disorders.
• Alcohol or drug abuse.
• Chronic use of opioids or benzodiazepines.

Критерии исключения

• Severe intraoperative complications.
• Duration of surgery longer than 5 hours.

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

Профилактика

Центры проведения

Tunisia · 1 центр

• Tunisia — Nabeul

Идентификаторы

NCT: NCT06272461 · UTEM ELKI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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