Polyuria Associated With Dexmedetomidine in Operating Room

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Polyuria
• Intervention / Treatment: Drug: Dexmedetomidine 0.004 MG/ML

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Cecilia M Acosta, MD; Phone Number: 542234990074; Email: ceacosta77@icloud.com
• Study Contact Backup: Name: Esteban Gandara, MD; Phone Number: 542234990099; Email: investigacion@hpc.org.ar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
determine if the appearance of polyuria is associated with other factors	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.	3 hours

Collaborators and Investigators

• Sponsor: Hospital Privado de Comunidad de Mar del Plata
• Investigators: Principal Investigator: Cecilia Acosta, MD, Hospital Privado de Comunidad

Study record dates

Study Major Dates

• Study Start (Estimated): August 10, 2024
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): January 10, 2025

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: anesthesia; dexmedetomidine; polyuria
• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Polyuria; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: HPC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No