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临床试验/NCT06535386
NCT06535386尚未招募不适用

Incidence of Polyuria Associated With Dexmedetomidine During the Intra-operative Period

Hospital Privado de Comunidad de Mar del Plata0 个研究点目标入组 150 人开始时间: 2024年8月10日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
主要终点
Incidence of polyuria associated with the administration of dexmedetomidine

研究概览

简要总结

Dexmedetomidine is an a2-adrenergic receptor agonist drug, widely used in intensive care for the sedation of patients on mechanical ventilation, as well as in the operating room during invasive procedures and during general anesthesia. It also has anti-inflammatory properties and reduces the need for opioids and benzodiazepines, which leads to a lower incidence of delirium associated with these drugs.

Among the frequent adverse effects associated with the administration of dexmedetomidine we can find bradycardia and hypotension, while some studies carried out in animals have shown that it can increase the diuretic rate.

Polyuria related to pharmacological agonism of a2-adrenergic receptors has been described in vitro and in studies performed in animal models, and is believed to be the result of functional antagonism of arginine vasopressin. Despite its widespread use as a sedative and adjunctive anesthetic, there are very few reports in the literature of dexmedetomidine-related polyuria in humans.

Currently there are no reports in the literature on the incidence of polyuria induced by the intraoperative administration of dexmedetomidine.

详细描述

This is a prospective, observational study designed to determine the incidence of polyuria, defined as urine output greater than 150 ml/h or 3 ml/kg/h, associated with the administration of dexmedetomidine during the intraoperative period.

The investigators will prospectively and consecutively study all patients scheduled for high complexity surgery under general anesthesia for a period of 4 months.

The diuretic rate will be quantified in ml/hour. A urine sample will be taken two hours after the start of surgery to assess sodium and urinary density, and an arterial blood sample will be taken to determine serum sodium.

Hydration will be recorded in milliliters per hour, detailing the type of solution used.

All data obtained will be captured in a RedCap data collection form.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years old
  • Scheduled surgery
  • Dexmedetomidine in boluses and/or continuous infusion during intra-operative period
  • Patients who require arterial line and urinary catheter

排除标准

  • Chronic renal disease.
  • eGFR < 60 ml/min/1.73m2 for more than 3 months of evolution.
  • Emergency or unscheduled surgeries.
  • Central nervous system disease at the sellar or suprasellar level.
  • Patients receiving diuretics.
  • Liver cirrhosis.
  • Adrenal gland disease.

结局指标

主要结局

Incidence of polyuria associated with the administration of dexmedetomidine

时间窗: 3 hours

Determine the incidence of polyuria defined as urine output greater than 150 ml/h or 3 ml/kg/h associated with the administration of dexmedetomidine during the intraoperative period in patients scheduled for highly complex surgery

次要结局

  • determine if the appearance of polyuria is associated with other factors(3 hours)

研究者

发起方
Hospital Privado de Comunidad de Mar del Plata
申办方类型
Other
责任方
Sponsor

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