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NCT Number: NCT06535386

Polyuria Associated With Dexmedetomidine in Operating Room

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Dexmedetomidine 0.004 MG/ML

Drug

Incidence of polyuria during the intraoperative period, associated with dexmedetomidine .

Primary outcomes

  1. Incidence of polyuria associated with the administration of dexmedetomidine

    Time frame: 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

Secondary outcomes

  1. determine if the appearance of polyuria is associated with other factors

    Time frame: 3 hours

    Determine if there is any correlation between the appearance of polyuria associated with the administration of dexmedetomidine and age, sex, type of surgery, other anesthetic drugs, and esophageal temperature.

Study contacts

Contact information is provided by the study sponsor or research team.

Cecilia M Acosta, MD

CONTACT

[email protected]

542234990074

Esteban Gandara, MD

CONTACT

[email protected]

542234990099

Sponsors and collaborators

Lead sponsor

Hospital Privado de Comunidad de Mar del Plata

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 2, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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