Safety and Efficacy Evaluation of S (+) - Ketamine in Adults

Summary

A multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of S (+) -ketamine for postoperative acute pain in adults in perioperative settings.

Conditions

• Postoperative Pain
• Adults
• Anesthesia

Interventions

DRUG

Conventional therapy + S (+)-Ketamine

Patients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction,maintenance or postoperative analgesia.

DRUG

Conventional therapy

Receiving conventional therapy without S (+)-Ketamine hydrochloride injection. There is no restrictions in drugs, doses and incompatibility, the researchers can choose appropriate medication regimens based on clinical practice, but other NMDA receptor antagonists are not be allowed to use, such as dextromethorphan and amantadine.

Sponsors & Collaborators

• Jiangsu Provincial People's Hospital

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

• Chinese PLA General Hospital

  lead OTHER

Principal Investigators

• Weidong Mi, MD · Chinese PLA General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-01

Primary Completion

2022-06-01

Completion

2022-06-30