NCT04657107

The Efficacy and Safety of S-ketamine in Elective Cesarean Section

The Efficacy and Safety of S-ketamine in Elective Cesarean Section: a Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 402 (estimated)
• Sponsor: Beijing Obstetrics and Gynecology Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anesthesia
• Analgesia
• Depression
• Cesarean Section
• Parturition

Interventions

Type	Name	Description
DRUG	S-ketamine	K1 group: pregnant women received 0.2mg/kg S-ketamine, intravenous drip;
OTHER	normal saline	Saline group: pregnant women received saline, intravenous drip
DRUG	S-ketamine	K2 group: pregnant women received 0.3mg/kg S-ketamine, intravenous drip;

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-12-15
• Completion: 2022-07-01
• First posted: 2020-12-08
• Last updated: 2020-12-08