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NOT YET RECRUITING
NCT07063108
PHASE4

Efficacy and Safety of S-ketamine in Elderly Patients Undergoing Non-cardiac Surgery: a RCT(ESSENCE)

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

This national, multi-center, randomized controlled study, through the study of intravenous injection of estaketamine in elderly patients undergoing surgery, is expected to explore whether estaketamine can improve the acute postoperative pain of elderly patients undergoing surgery and reduce the incidence of postoperative depression and delirium.

Official title: Efficacy and Safety of S-ketamine Hydrochloride Injection in Elderly Patients Undergoing Elective Non-cardiac Surgery: a Multicenter, Randomized, Placebo Controlled Clinical Trials(ESSENCE)

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

276

Start Date

2025-12-01

Completion Date

2026-12-31

Last Updated

2025-07-14

Healthy Volunteers

No

Interventions

DRUG

Esketamine hydrochloride

Intravenous infusion of esketamine: after induction, a single dose of 0.25 mg/kg before skin incision,and continuous 0.125 mg/kg/h until 30 min before surgery was stopped.

DRUG

Saline

after induction, a single intravenous infusion of an equal amount of 0.9% saline before skin incision, followed by a continuous infusion at the same rate as the test group until 30 min before surgical cessation.