None listed
Conditions
Interventions
Experimental group:Esketamine injection was given intravenously
Control group:None
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years (including the critical value), gender is not limited; 2. Patients undergoing elective general anesthesia laparoscopic surgery (only for endotracheal intubation and mechanical ventilation), 1 hour <= expected anesthesia time <= 2.5 hours; 3. American Society of Anesthesiologists (ASA) grade I or II; 4. 18kg/m^2 < BMI < 30kg/m^2; 5. Patients understood the purpose and procedure of this trial, voluntarily participated in this trial, and signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those with contraindications to general anesthesia, or those who have experienced anesthesia accidents in the past; 2. Those who are known to be intolerant or allergic to ketamine hydrochloride, esketamine hydrochloride, propofol, rocuronium bromide, opioids, neostigmine, atropine, belladonna alkaloids; 3. Long-term (continuous or intermittent) use of benzodiazepine sleeping pills, opioid analgesics, or narcotic analgesics within 24 hours or narcotic drugs within 7 days before randomization; 4. Those with a history of elevated intraocular pressure (such as glaucoma) or puncture eye injury; 5. Those with a history of asthma; 6. Those with mental system diseases (schizophrenia, mania, insanity, etc.) or cognitive dysfunction; 7. Those with a history of craniocerebral injury, possible intracranial hypertension, cerebral aneurysm, cerebrovascular accident and central nervous system diseases; 8. Have a history of severe cardiovascular disease (such as: myocardial ischemia, heart failure and severe arrhythmia, etc.); angina pectoris (unstable angina pectoris) due to insufficient blood supply to the coronary artery, or myocardial infarction within 6 months before screening ; 9. Hypertensive patients with systolic blood pressure >= 140mmHg, and/or diastolic blood pressure still >=90mmHg after antihypertensive drug treatment; 10. Diabetics with unsatisfactory control of blood sugar (fasting blood sugar >= 11.1mmol/L during the screening period); 11. Patients with severe lipid metabolism abnormalities (such as triglyceride > 5mmol/L, diabetic hyperlipidemia, familial hypercholesterolemia, lipoid nephropathy, acute pancreatitis with hyperlipidemia, etc.); 12. Those with a history of hyperthyroidism; 13. Those who have a history of drug use within 2 years before screening; 14. Those with a history of alcoholism within 2 years before screening, alcoholism means drinking more than 14 units of alcohol per week (1 unit = 360mL of beer or 45mL of spirits with an alcohol content of 40% or 150mL of wine) or acute alcoholism or alcohol dependence; 15. Those who have participated in any clinical trial within 3 months before screening (defined as receiving trial drug or placebo); 16. Those who are judged by the investigator to be difficult to manage the respiratory tract (improved Markov score is grade IV); 17. Abnormal coagulation function (PT or PT-INR >= 1.5 x ULN, APTT >= 1.5 x ULN), or those with bleeding tendency (such as active peptic ulcer) or those who are receiving thrombolytic or anticoagulant therapy; 18. Anemia or thrombocytopenia (PLT = 1.5 x ULN, TBIL >= 1.5 x ULN]; 20. Patients with abnormal renal function (BUN >= 1.5 x ULN; Cr >= 1.2 x ULN); 21. Pregnant or lactating patients; fertile patients are unwilling to use contraception from the screening period to the end of the trial; 22. Patients who are considered by the investigator to have any other factors that are not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton's Depression Scale;Fully awake time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Vigilance/Sedation Score;American Society of Anesthesiologists Classification;Mini-Intelligence Mental State Examination Scale;Anesthesiologist Satisfaction Questionnaire;Blood pressure;Heart rate, pulse;Breathe;Numerical Scale Pain Score; | — |
Countries
China
Contacts
Public ContactOuyang Wen
Outcome results
None listed