Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty

Официальное название

Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty: Prospective Randomized Controlled Blinded Study

Обзор

The aim of this study is to assess the effect of oral melatonin versus intraoperative lidocaine infusion on incidence of postoperative delirium in elderly patients undergoing total hip arthroplasty under spinal anesthesia.

Подробное описание

Delirium is defined according to The American Psychiatric Association's fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), as disturbance in attention and awareness developed over a short period of time , its severity tends to fluctuate during the course of a day, these disturbances cannot be better explained by other pre-existing neurocognitive disorders and do not occur in severely reduced arousal level such as coma. Delirium can be further classified into hyperactive, hypoactive and mixed.Postoperative delirium (POD) usually occurs in the recovery room and appears up to 5 days after surgery.

The prevalence of POD in elderly patients undergoing surgery varies from 20% to 45%. Patients undergoing hip fracture surgery are at higher risk of POD than patients undergoing other types of surgery. This may be related to their older age, higher incidence of comorbidities, and greater physical weakness.

Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone that is discharged by the pineal gland produced from the amino acid tryptophan. Synthetic melatonin has been effectively utilized in the treatment of sleep disorders. It was likewise utilized as a premedication and it provided excellent anxiolysis, sedation, and sympatholytic impacts with the merit of not influencing the patients' cognition in addition to its analgesic effect.

Lidocaine, an amide local anesthetic and class-1 antiarrhythmic with sedative and anti-inflammatory properties, is increasingly used as a part of a multimodal intraoperative anesthetic adjunct in a variety of surgical procedures.

Вмешательства

• Препарат Melatonin
  Patients will receive one capsule of melatonin (5mg) orally the night before surgery at 9 pm, the night of the operation, and two nights after the surgical operation at 9 pm, also the patients will receive 10 ml bolus of saline intravenous (IV) over 10 min before induction of anesthesia, then continuous infusion of saline (20 ml/hr) until the end of surgery.
• Препарат Lidocaine
  Patients will receive a bolus (10 ml) of intravenous lidocaine (1mg/kg) diluted with saline over 10 min before induction of anesthesia. Continuous infusion of 1.5 mg/kg/hr of intravenous lidocaine diluted with saline (20 ml/hr) will be administered until the end of the surgery, also will receive placebo capsule the night before surgery at 9 pm, the night of operation and two nights after the surgical operation at 9 pm.
• Препарат Placebo
  Patients will receive a bolus (10 ml) of saline over 10 min before induction of anesthesia, then continuous infusion of saline (20 ml/hr) and placebo capsule the night before surgery at 9 pm, the night of the operation and two nights after the surgical operation at 9 pm.

Первичные конечные точки

• The incidence of postoperative delirium (POD) [Срок оценки: 1st five days postoperatively]

Вторичные конечные точки (6)

• Severity of delirium [Срок оценки: 1st five days postoperatively]
• Onset of delirium [Срок оценки: 1st five days postoperatively]
• Duration of delirium [Срок оценки: 1st five days postoperatively]
• Degree of pain [Срок оценки: 24 hours postoperatively]
• Length of hospital stay [Срок оценки: Till the discharge from the hospital (up to 2 weeks).]
• Adverse effects [Срок оценки: 24 hours Postoperatively]

Критерии участия

Критерии включения

• Elderly patients aged >65 years old undergoing unilateral total hip arthroplasty.
• Patients with body mass index (BMI) (18-30) kg/m2.
• American Society of Anesthesiologists (ASA) physical status I-III, scheduled to undergo unilateral total hip arthroplasty.

Критерии исключения

• History of mental illness or scoring less than 8 using abbreviated mental test (AMT) before operation.
• Obvious sinus bradycardia (heart rate of <50 beats per minute) or other serious cardiovascular diseases.
• Symptomatic cerebrovascular disease (such as previous stroke).
• History of liver and kidney dysfunction.
• Allergy to lidocaine or melatonin.
• Metabolic disorders and fluid, electrolytes disturbances.
• Alcohol dependence or drug abuse.
• Redo surgery or infectious complications.
• CNS medications (antipsychotics, anticonvulsants, antiparkinsonian, antidepressants).
• History of deep vein thrombosis.

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

Лечение

Центры проведения

Египет · 1 центр

• Tanta University — Tanta

Идентификаторы

NCT: NCT06768580 · 36265MD277/9/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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