ClinicalTrials.gg
Not yet recruitingNCT06535386Updated Aug 7, 2024

Polyuria Associated With Dexmedetomidine in Operating Room

An observational study in Polyuria, sponsored by Hospital Privado de Comunidad de Mar del Plata. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Hospital Privado de Comunidad de Mar del Plata · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Polyuria

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Keywords

  • dexmedetomidine
  • polyuria
  • anesthesia
03

In context

Polyuria

14 studies on the registry are indexed under Polyuria; 2 are open to participants now.

Browse Polyuria studies →

Lead sponsor

Hospital Privado de Comunidad de Mar del Plata is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Chronic renal disease.
  • \< 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Interventions

  • DrugDexmedetomidine 0.004 MG/ML

    Drug page: Dexmedetomidine

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

06

What researchers measure

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

    Time frame: 3 hours

Secondary outcomes

  1. 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.

    Time frame: 3 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2024; primary completion for Dec 2024, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2024
First posted
Aug 2, 2024
StartEst.
Aug 10, 2024
Primary completionEst.
Dec 15, 2024
CompletionEst.
Jan 10, 2025
Last update
Aug 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06535386
Lead sponsor
Hospital Privado de Comunidad de Mar del Plata
Responsible party
Sponsor
First posted
Aug 2, 2024
Start date
Aug 10, 2024 (estimated)
Primary completion
Dec 15, 2024 (estimated)
Completion
Jan 10, 2025 (estimated)
Last update
Aug 7, 2024

Study contacts

Cecilia M Acosta, MD
Contact
ceacosta77@icloud.com
542234990074
Esteban Gandara, MD
Contact
investigacion@hpc.org.ar
542234990099
Cecilia Acosta, MD
principal investigator · Hospital Privado de Comunidad

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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