Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04657107
Status:
UNKNOWN
Last Update Posted:
2020-12-08
First Post:
2020-12-01
Brief Title:
The Efficacy and Safety of S-ketamine in Elective Cesarean Section
Sponsor:
Beijing Obstetrics and Gynecology Hospital
Organization:
Beijing Obstetrics and Gynecology Hospital
Study Overview
Official Title:
The Efficacy and Safety of S-ketamine in Elective Cesarean Section a Multi-center Randomized Double-blind Placebo-controlled Clinical Study
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
NOT_YET_RECRUITING
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:
ES-CS
Brief Summary:
During the past years a large number of clinical trials have investigated the use of the non-competitive N-methyl-D-aspartate NMDA receptor antagonist racemic ketamine as an adjunct to local anaesthetics opioids or other analgesic agents for the management and prevention of postoperative pain Actually racemic ketamine not only abolishes peripheral afferent noxious stimulation but can also prevent the central nociceptor sensitization S-ketamine one of two enantiomers of racemic ketamine has twice the analgesic potency of the racemate Moreover S-ketamine shows smaller nervous system and less psychotropic effects than racemic ketamine which may make the drug more suitable for clinical use Recently S-ketamine has been approved to treat refractory depression TRD and major depressive disorder MDD by the FDA S-ketamine may have greater clinical significance due to the high rate of maternal depression Therefore we plan to explore whether clinical use of S-ketamine can optimize anesthesia protocol and improve maternal prognosis
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None