Postoperative pain
Conditions
Interventions
Anrikofen high-dose group:Anrikefon injection i.v. 2ug/kg
Anrikofen mid-dose group:Anrikefon injection i.v. 1.5ug/kg
Anrikofen low-dose group:Anrikefon injection i.v. 1.0ug/kg
Sufentanil group:Sufentanil i.v. 0.1ug/kg
Sponsors
The First Affiliated Hospita Zhejiang University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years old; 2. American Society of Anesthesiologists (ASA) classification I-II; 3. Subjects scheduled for elective laparoscopic gynecological surgery under general anesthesia, with an expected surgery duration of at least 2 hours; 4. Agree to participate in this trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with BMI> 30 kg/m^2 or 500ms; 3. Patients with a previous history of respiratory disease: severe chronic obstructive pulmonary disease, acute onset of chronic obstructive pulmonary disease, severe airway stenosis, throat mass, history of (bronco)tracheoesophageal fistula or airway tear, severe respiratory infection within the past 2 weeks before screening; 4. Patients with a history of neurological and psychiatric diseases: severe head injury, convulsions, intracranial hypertension, cerebral aneurysm, and cerebrovascular accident; schizophrenia, mania, confusion, long-term use of psychotropic drugs, history of cognitive dysfunction, etc.; depression, anxiety; severe central nervous system depression state, Parkinson's syndrome, basal ganglion lesion, epilepsy, Alzheimer's disease, myasthenia gravis, etc.; 5. Patients with a history of acute poisoning with alcohol, sleeping pills, analgesics or other drugs that act on the central nervous system; 6. Patients with severe renal insufficiency who need dialysis before surgery; 7. Patients with severe hepatic insufficiency (Child-Pugh grade C); 8. Patients who are expected to continue endotracheal intubation after surgery; 9. Patients who need to have an indwelling gastric tube after surgery; 10. Known allergy or contraindication to opioids and other anesthetics and antiemetics that may be used during the trial; 11. Drugs with analgesic effects were used before surgery, and the last use time was shorter than 5 half-lives or the duration of drug efficacy (calculated as the longest time) from the random time, including but not limited to opioid analgesics, non-opioid analgesics sedative-hypnotics, non-benzodiazepines, sedative anesthetics, glucocorticoids, antiepileptic drugs, anxiolytics, antidepressants, and Chinese herbal medicines or proprietary Chinese medicines with analgesic and sedative effects. 12. History of drug abuse or preoperative alcohol dependence within 3 months before screening (drinking more than three times the standard alcoholic beverages per day, approximately equal to 10g of alcohol or equivalent to 50g of Chinese liquor); 13. Participated in any clinical investigator within 3 months before screening; 14. Known pregnancy or lactating females; 15. Subjects who have any other factors that the investigator considers unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the time curve of resting NRS score within 8 hours of the investigational drug; | — |
Secondary
| Measure | Time frame |
|---|---|
| The effective number of PCIA compressions and sufentanil consumption;The proportion of patients who use salvage antiemetic;Time from the end of the patient's surgery to extubation;Resting NRS pain score;The proportion of rescue analgesia and the dosage of rescue drugs;The proportion of nausea or vomiting occurring;nausea NRS score;NRS pain scores during activities;Ramsay score; | — |
Countries
China
Contacts
Public ContactSu Diansan
The First Affiliated Hospita Zhejiang University School of Medicine
Outcome results
None listed