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

Not Applicable

Not yet recruiting

• Conditions: Postoperative Pain
• Interventions: Drug: Esketamine hydrochloride; Drug: Saline

• Registration Number: NCT07063108
• Lead Sponsor: Chinese PLA General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-27
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-03
• Last Update Submitted: 2025-07-03
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Study Start: 2025-12-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

• 1. Aged > 65 years old, no gender limitation;
• 2. patients undergoing elective thoracic, abdominal and orthopedic surgery;
• 3. ASA score is Class I-Class ~III;
• 4. 18 kg/ m2<BMI<30kg/m2；
• 5. The operation time is estimated to be 2 h-4 h;
• 6. Know clearly and voluntarily participate in this study, and sign informed consent form by oneself.

Exclusion Criteria

• 1. patients with severe chronic pain;
• 2. Anemia or thrombocytopenia, Hb < 90 g/L, PLT < 80 × 109/L;
• 3. Severe liver dysfunction, AST and/or ALT≥2.5×ULN, and TBIL ≥ 1.5 × ULN;
• 4. severe renal dysfunction, blood creatinine is greater than the upper limit of normal;
• 5. Severe cardiovascular history (such as myocardial ischemia, heart failure and arrhythmia); Angina pectoris (unstable angina pectoris) caused by insufficient blood supply to the coronary vessels of the heart, or myocardial infarction in the past 6 months; QT interval prolongation (≥460ms in males and ≥ 470 ms in females);
• 6. Patients with hypertension whose blood pressure is not satisfactorily controlled by antihypertensive drugs (systolic blood pressure in sitting position during screening stage ≥180 mmHg, and/or diastolic blood pressure during screening stage ≥ 100 mmHg);
• 7. Patients with craniocerebral injury, possible intracranial hypertension, cerebral aneurysm, cerebrovascular accident history and central nervous system disease history;
• 8. patients with glaucoma or serious increase in intraocular pressure risk;
• 9. patients with mental system diseases (schizophrenia, mania, bipolar disorder, mental disorder, etc.) and drug history and cognitive dysfunction; History of cognitive psychiatric disorders such as postoperative delirium; Pregnant or lactating women;
• 10. high risk surgery, is expected to enter the ICU after surgery;
• 11. to moxa ketamine hydrochloride and its drug components allergy or taboo;
• 12. Being a subject and having participated in clinical trials for other drugs in the past three months;
• 13. There is communication disorder;
• 14. Patients considered by the investigator to be ineligible for participation in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group (esketamine injection)	Esketamine hydrochloride	Test group (esketamine injection group)： 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.
Control group (placebo: saline)	Saline	Control group (placebo: 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 surgery was stopped.

Primary Outcome Measures

Name	Time	Method
NRS pain score at the 24th hour after operation.	24th hour after operation	NRS pain score at the 24th hour after operation.

Secondary Outcome Measures

Name	Time	Method
NRS pain scores at the 2nd hour, 48th hour and 72nd hour after operation.	the 2nd hour, 48th hour and 72nd hour after operation.	NRS pain scores at the 2nd hour, 48th hour and 72nd hour after operation.
The incidence of delirium within 72 hours after operation	72 hours after operation
The evaluation of APS-POQ-R questionnaire at 24 hours, 48 hours and 72 hours after operation.	24 hours, 48 hours and 72 hours after operation.	The evaluation of APS-POQ-R questionnaire at 24 hours, 48 hours and 72 hours after operation.
The scores of Montgomery Depression Scale at 24th hour, 48th hour and 72nd hour after operation.	24th hour, 48th hour and 72nd hour after operation.
The consumption of anesthetic and analgesic drugs during and within 72 hours after operation.	during and within 72 hours after operation.
The score of GAD-7 anxiety scale 72 hours after operation. The incidence of delirium within 72 hours after operation	72 hours after operation
The incidence of adverse events during and within 72 hours after operation.	72 hours after operation.