Effect of Low-dose EsketaMine on dElirium in High-risk Elderly Patients uNdergoing elecTive Surgery (ELEMENT)

NARecruitingINTERVENTIONAL
Enrollment

1,670

Participants

Timeline

Start Date

February 12, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

July 31, 2027

Conditions
Delirium in Old AgeDelirium, PostoperativeAnesthesiaCognitive DysfunctionPain, PostoperativeEsketamineNon-cardiac Surgery
Interventions
DRUG

Esketamine

Esketamine (1mg/ml) will be administered at a loading dose of 0.2 mg/kg, namely at a infusion rate of 1.2ml/kg/h over 10 minutes after induction, then a maintenance infusion rate of 0.1 mg/kg/h until 40 minutes before the end of the surgery. For postoperative analgesia, patient-controlled intravenous analgesia (PCIA) is prepared with a formulation consisting of esketamine 50mg and sufentanil 200 μg, diluted to a total volume of 200 ml. The background dose is set at 2 ml/h, with a bolus dose of 2 ml and a lockout interval of 15 minutes.

DRUG

Normal saline

Normal saline will be administered at a infusion rate of 1.2ml/kg/h over 10 minutes after induction, then a maintenance infusion rate of 0.1 mg/kg/h until 40 minutes before the end of the surgery. For postoperative analgesia, patient-controlled intravenous analgesia (PCIA) is prepared with sufentanil 200μg, diluted to a total volume of 200 ml. The background dose is set at 2 ml/h, with a bolus dose of 2 ml and a lockout interval of 15 minutes.

Trial Locations (6)

341001

ACTIVE_NOT_RECRUITING

Ganzhou People's Hospital, Ganzhou

350001

RECRUITING

Fujian Provincial Hospital, Fuzhou

510060

NOT_YET_RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

510515

RECRUITING

Nanfang Hospital, Southern Medical University, Guangzhou

510632

ACTIVE_NOT_RECRUITING

The First Affiliated Hospital of JiNan University, Guangzhou

528399

RECRUITING

The Eighth Affliated Hospital of Southern Medical Universily, Guangzhou

All Listed Sponsors
lead

Nanfang Hospital, Southern Medical University

OTHER