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

Launched by CHINESE PLA GENERAL HOSPITAL · Jul 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medicine called S-ketamine, given through an IV, can help older adults (over 65 years old) feel less pain right after surgery and reduce problems like depression and confusion that sometimes happen after surgery. The study focuses on patients having planned (elective) surgeries on the chest, belly, or bones, and who are generally in fair health.

If you choose to join, you can expect to receive S-ketamine during your surgery and the medical team will carefully watch how well it manages your pain and whether it affects your mood or mental clarity afterward. To be eligible, you need to be over 65, have a surgery lasting about 2 to 4 hours, and meet certain health requirements like having a stable heart and kidney function. People with serious health issues, certain eye problems, or mental health conditions, as well as pregnant women, will not be able to participate. This study is not yet recruiting participants but aims to find safer, more effective ways to manage pain and improve recovery in older patients after surgery.

Gender

ALL

Eligibility criteria

• 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.