Postoperative pain
Conditions
Interventions
Anrikofen high-dose group:Loading dose of Anrikefen 1µg/kg (dilute 1ml of Anrikefen injection stock solution to 10ml, then calculate the dose according to body weight and withdraw the corresponding vo
The PCIA parameters are: background dose of 1ml/h, bolus dose of 4ml, and lockout time of 15 minutes.
Anrikofen low-dose group:Loading dose of Anrikefen 1µg/kg (dilute 1ml of Anrikefen injection stock solution to 10ml, then calculate the dose according to body weight and withdraw the corresponding vol
Sufentanil group:Loading dose of sufentanil 0.1ug/kg (intravenous injection), PCA pump: sufentanil 100ug (2 vials), diluted to 100ml with normal saline
Sponsors
Jiangsu Provincial People's Hospital
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 of I-II; 3.18 kg/m^2<= BMI <=30 kg/m^2; 4. For patients undergoing laparoscopic gynecological surgery under general anesthesia at a later date, the estimated duration of the surgery is at least 1 hour; 5. Agree to participate in this trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of severe cardiovascular disease; 2. Patients with a history of respiratory diseases: severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, pharyngeal or laryngeal masses, history of (broncho-)tracheoesophageal fistula or airway laceration, and severe respiratory infection within the past 2 weeks before screening; 3. Patients with previous neurological and psychiatric history: severe head injury, intracranial hypertension, cerebral aneurysm, cerebrovascular accident, convulsions, etc.; schizophrenia, mania, mental disorder, long-term use of psychotropic drugs, cognitive dysfunction, etc.; depression, anxiety; severe central nervous system depression, Parkinson's syndrome, basal ganglia lesions, epilepsy, Alzheimer's disease, myasthenia gravis, etc; 4. Patients with a history of acute intoxication from alcohol, hypnotics, analgesics, or other central nervous system drugs; 5. Patients with severe renal insufficiency; 6. Patients who require conversion to open surgery during laparoscopic surgery or who need to be transferred to the ICU after surgery; 7. Patients who are expected to require continued tracheal intubation after surgery; 8. Patients who require a gastric tube placement after surgery; 9. Known allergy or contraindication to opioids and other anesthetics and antiemetics that may be used during the trial; 10. Before surgery, analgesic drugs were administered, and the time since the last administration was less than 5 half-lives or the duration of drug efficacy (calculated based on the longest time), including but not limited to opioid analgesics, non-opioid analgesics, sedative hypnotics, non-benzodiazepines, sedative anesthetics, glucocorticoids, antiepileptic drugs, anxiolytics, antidepressants, as well as Chinese herbal medicines or traditional Chinese patent medicines and simple preparations with analgesic and sedative effects; 11. Those with a history of drug abuse within the previous 3 months or preoperative alcohol dependence (consuming more than three standard alcoholic drinks per day, equivalent to approximately 10g of alcohol or 50g of Chinese Baijiu) shall be excluded from the screening process; 12. Screen out those who have participated in any clinical research within the previous 3 months; 13. Known to be pregnant or breastfeeding; 14. Subjects who, in the opinion of the investigator, have any other factors that make them unsuitable to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve of rest pain scores from 0 to 48 hours (AUC0-48h); | — |
Secondary
| Measure | Time frame |
|---|---|
| Resting NRS score, active NRS score, incision pain NRS score, and visceral pain NRS score at various time points (1h, 2h, 4h, 8h, 16h, 24h, 36h, 48h) within 48 hours after surgery;Total PCA presses and effective PCA presses within 24 and 48 hours after surgery;The proportion of patients receiving rescue analgesia within 24 and 48 hours after surgery, and the cumulative amount of rescue medication used;The incidence of nausea or vomiting within 0-24 hours, 24-48 hours, and 0-48 hours after surgery;Investigate the satisfaction ratings of doctors and patients towards analgesia treatment;Safety: Incidence and severity of adverse events; | — |
Countries
China
Contacts
Public ContactYang Jiianjun; Peng Peipei
Jiangsu Provincial People's Hospital
Outcome results
None listed