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

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

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;

Sponsors & Collaborators

• China Health Promotion Foundation

  collaborator UNKNOWN

• Beijing Haidian Maternal and Child Health Hospital

  collaborator OTHER

• Obstetrics & Gynecology Hospital of Fudan University

  collaborator OTHER

• The Fourth Hospital of Shijiazhuang

  collaborator OTHER

• Changzhi Maternal and Child Health Hospital

  collaborator UNKNOWN

• Linfen Maternity&Child Healthcare Hospital

  collaborator UNKNOWN

• Maternal and Child Health Hospital, Jiading District

  collaborator OTHER

• Tongzhou Maternal and Child Healthcare Hospital of Beijing

  collaborator UNKNOWN

• Beijing Chaoyang District Maternal and Child Health Care Hospital

  collaborator UNKNOWN

• Beijing Obstetrics and Gynecology Hospital

  lead OTHER

Principal Investigators

• Lei Wang · Beijing Haidian Maternal and Child Health Hospital

• Shaoqiang Huang · Obstetrics & Gynecology Hospital of Fudan University

• Jin Zhang · The Fourth Hospital of Shijiazhuang

• Yingbin Ren · Changzhi Maternal and Child Health Hospital

• Yong Qin · Linfen Maternity&Child Healthcare Hospital

• Shenghua Li · Maternal and Child Health Hospital, Jiading District

• Zhenhuan Hou · Tongzhou Maternal and Child Healthcare Hospital of Beijing

• Shuyi Miao · Beijing Chaoyang District Maternal and Child Health Care Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-12-01

Primary Completion

2021-12-15

Completion

2022-07-01