Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608030
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Effect of Esketamine on Perioperative Negative Mood in Patients Undergoing Cardiac Valve Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of a Single Dose of Esketamine on Perioperative Negative Mood in Patients Undergoing Cardiac Valve Surgery a Randomized Controlled Trial
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:
A multicenter randomized controlled blinded prospective study to investigate the effects of esketamine on perioperative anxiety and depression in patients undergoing cardiac valve surgery
Detailed Description:
Undergoing surgery can be a traumatic and painful experience for patients often causing negative moods such as anxiety and depression The size and type of surgery significantly impact the occurrence of anxiety and depression in patients Approximately one-third of patients after cardiac surgery experience anxiety or depression which increases the risk of recurrent cardiovascular events and death
Ketamine is an anesthetic drug with comprehensive effects including analgesia sedation and amnesia Its primary mechanism of action is blocking N-methyl-D-aspartate NMDA receptors Esketamine the pure dextro isomer of ketamine has a higher affinity for glutamate NMDA receptors and opioid receptors offering stronger sedative analgesic and antidepressant effects On March 4 2019 esketamine was approved by the FDA for treatment-resistant depression Given its analgesic anesthetic and antidepressant effects esketamine may be an ideal drug for improving negative moods in patients undergoing cardiac surgery
Ketamine is an anesthetic drug with comprehensive effects including analgesia sedation and amnesia Its primary mechanism of action is blocking N-methyl-D-aspartate NMDA receptors Esketamine the pure dextro isomer of ketamine has a higher affinity for glutamate NMDA receptors and opioid receptors offering stronger sedative analgesic and antidepressant effects On March 4 2019 esketamine was approved by the FDA for treatment-resistant depression Given its analgesic anesthetic and antidepressant effects esketamine may be an ideal drug for improving negative moods in patients undergoing cardiac surgery
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