Ignite Creation Date:
2024-07-17 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468436
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-15
Brief Title:
Dexmedetomidine-Esketamine Combination for Sedation and Analgesia in ICU Patients
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
Effect of Dexmedetomidine-Esketamine Combination for Sedation and Analgesia on Delirium in ICU Patients With Mechanical Ventilation A Multicenter Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with mechanical ventilation in the intensive care unit ICU often develop anxiety and agitation sleep distuebances and delirium Delirium occurrence is associated with worse early and long-term outcomes Dexmedetomidine and ketamine are recommended for sedation and analgesia in ICU patients but each may induce side effects The sedative effects of dexmedetomidine can help mitigate the psychiatric side effects of esketamine Recent studies showed that dexmedetomidine-esketamine combination improved analgesia and sleep quality without increasing psychiatric side effects This trial is designed to test the hypothesis that dexmedetomidine-esketamine combination for sedation and analgesia in ICU patients with mechanical ventilation may reduce delirium and improve respiratory recovery
Detailed Description:
Patients with respiratory failure or other severe conditions often require non-invasive or invasive mechanical ventilation in the Intensive Care Unit ICU The uncomfortable stimulation produced by mechanical ventilation may lead to anxiety and agitation of patients and adverse consequences such as ventilator asynchrony increased oxygen consumption stress responses self-extubation and potentially prolonged mechanical ventilation The above factors together with the ICU environment underlying illnesses treatment measures and painful procedures often result in sleep disturbances in ICU patients
Mechanical ventilation painful stimulation and sleep disturbances are important risk factors of delirium in ICU patients Delirium is an acutely occurred brain dysfunction symdrome characteristized with fluctuating disturbances in attention cognition and consciousness and is reported to occur in up to 80 of ICU patients with mechanical ventilation Delirium occurrence is associated with worse outcomes including prolonged mechanical ventilation duration extended ICU and hospital stays increased healthcare burden and costs and elevated mortality risk as well as long-term sequelae including cognitive decline reduced quality of life and decreased survival
Dexmedetomidine is a highly selective α2-adrenergic receptor agonist with sedative analgesic and anxiolytic effects It exerts effects by activating the endogenous sleep-promoting pathways inducing a state like non-rapid eye movement sleep Ketamine is a non-competitive N-methyl-D-aspartate NMDA receptor antagonist Esketamine the more potent enantiomer of ketamine has a higher affinity for the NMDA receptor and is approximately twice as potent as ketamine with a lower incidence of adverse effects Both dexmedetomidine and ketamine are recommended for sedation and analgesia in ICU patients However sedative dose dexmedetomidine is associated with bradycardia and hypotension Even low-dose esketamine can induce psychotropic side effects such as dissociation hallucinations and nightmares
The sedative effects of dexmedetomidine can help mitigate the psychiatric side effects of esketamine Recent studies showed that dexmedetomidine-esketamine combination improved analgesia and sleep quality without increasing psychiatric side effects It is hypothesized that dexmedetomidine-esketamine combination for sedation and analgesia in ICU patients with mechanical ventilation may reduce delirium and improve respiratory recovery
Mechanical ventilation painful stimulation and sleep disturbances are important risk factors of delirium in ICU patients Delirium is an acutely occurred brain dysfunction symdrome characteristized with fluctuating disturbances in attention cognition and consciousness and is reported to occur in up to 80 of ICU patients with mechanical ventilation Delirium occurrence is associated with worse outcomes including prolonged mechanical ventilation duration extended ICU and hospital stays increased healthcare burden and costs and elevated mortality risk as well as long-term sequelae including cognitive decline reduced quality of life and decreased survival
Dexmedetomidine is a highly selective α2-adrenergic receptor agonist with sedative analgesic and anxiolytic effects It exerts effects by activating the endogenous sleep-promoting pathways inducing a state like non-rapid eye movement sleep Ketamine is a non-competitive N-methyl-D-aspartate NMDA receptor antagonist Esketamine the more potent enantiomer of ketamine has a higher affinity for the NMDA receptor and is approximately twice as potent as ketamine with a lower incidence of adverse effects Both dexmedetomidine and ketamine are recommended for sedation and analgesia in ICU patients However sedative dose dexmedetomidine is associated with bradycardia and hypotension Even low-dose esketamine can induce psychotropic side effects such as dissociation hallucinations and nightmares
The sedative effects of dexmedetomidine can help mitigate the psychiatric side effects of esketamine Recent studies showed that dexmedetomidine-esketamine combination improved analgesia and sleep quality without increasing psychiatric side effects It is hypothesized that dexmedetomidine-esketamine combination for sedation and analgesia in ICU patients with mechanical ventilation may reduce delirium and improve respiratory recovery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None