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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Not yet enrolling; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Esketamine hydrochloride; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07063108

2022-698

Details and patient eligibility

About

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.

Enrollment: 276 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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276 participants in 2 patient groups, including a placebo group

Test group (esketamine injection)

Experimental group

Description:

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.

Treatment:

Drug: Esketamine hydrochloride

Control group (placebo: saline)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline