Polyuria Associated With Dexmedetomidine in Operating Room

NCT06535386 | Not Yet Recruiting DMC FDA Drug

• 1 other identifier: HPC
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Polyuria

Keywords

dexmedetomidine; polyuria; anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of polyuria associated with the administration of dexmedetomidine

  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

  3 hours

Secondary Outcomes (1)

• determine if the appearance of polyuria is associated with other factors

  3 hours

Interventions

Dexmedetomidine 0.004 MG/ML DRUG

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of both sex and age, over 18-year-old, ASA I - II - III scheduled for high complexity surgery under general anesthesia who receive dexmedetomidine intra-operatively and who require arterial line and urinary catheter, for a period of 4 months.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Privado de Comunidad de Mar del Plata: lead

MeSH Terms

Conditions

Polyuria

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Cecilia Acosta, MD

  Hospital Privado de Comunidad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilia M Acosta, MD

CONTACT

542234990074; ceacosta77@icloud.com

Esteban Gandara, MD

CONTACT

542234990099; investigacion@hpc.org.ar

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: August 10, 2024
• Primary Completion: December 15, 2024
• Study Completion: January 10, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-07