NCT07063108

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2025-07-14
• Last updated: 2025-07-14