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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• NRS pain score at the 24th hour after operation. [Time frame: 24th hour after operation]

Secondary outcome measures (7)

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07063108 · 2022-698

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗