Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535386
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Polyuria Associated With Dexmedetomidine in Operating Room
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Incidence of Polyuria Associated With Dexmedetomidine During the Intra-operative Period
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
This is a prospective observational study designed to determine the incidence of polyuria defined as urine output greater than 150 mlh or 3 mlkgh 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 mlhour 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
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 mlhour 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None