Pain
Conditions
Interventions
Group 1 :0.5 ug/kg experimental drugs
Group 2:1 ug/kg experimental drugs
Group 3:2 ug/kg experimental drugs
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study, signed the informed consent, and complied with the visit and related procedures stipulated by the program; 2. Age >= 18 years and <= 65 years at the time of signing the informed consent, regardless of gender; 3. For subjects undergoing elective abdominal endoscopic surgery under general anesthesia, the operation duration is expected to be 1 h to 3 h (including 1 h and 3 h); 4. Screening period: 45 kg <= body weight <= 100 kg, 18.5 kg/m2 <= body mass index (BMI) < 28 kg/m2; 5. American Society of Anesthesiologists (ASA) grading standard I-III.
Exclusion criteria
Exclusion criteria: 1. Previous history of stroke, and/or clear history of neurological or psychiatric disorders; 2. Patients with previous cognitive dysfunction or history of epilepsy; 3. Previous history of pituitary surgery or radiotherapy; patients with abnormal prolactin within 1 year before signing the informed consent and judged by the researchers to have clinical significance (including but not limited to pituitary tumor/microadenoma, polycystic ovary syndrome, etc.); 4. Previous history of thyroid surgery, iodine-131 treatment and/or other thyroid diseases (including but not limited to hyperthyroidism, hypothyroidism, etc.); 5. Patients with conjunctival diseases requiring treatment within 1 month before signing the informed consent; 6. Patients with a history of difficult airway and respiratory diseases, including but not limited to obstructive sleep apnea syndrome, airway obstruction or tissue hypoxia, asthma history, etc., which the investigators judged to be clinically significant; 7. Continuous use of opioid analgesics for any reason for more than 10 days within the 3 months prior to the signing of the informed consent, or less than 5 half-lives or the longest duration of efficacy (calculated as maximum) of any of the following medications, including opioid or non-opioid analgesics, or other medications determined by the investigator to affect the efficacy of the analgesics: sedative hypnotic drugs (benzodiazepines (triazolam, valium, midazolam, etc.)), non-steroidal anti-inflammatory drugs (aspirin, acetaminophen, indomethacin, diclofenac, ibuprofen, palacecob sodium, etc.), a2 receptor agonists (dexmedetomidine hydrochloride, clonidine), etc.; 8. People who are known to be allergic to opioids (including the drugs used during and after surgery) and the drugs and excipients to be used in this study; 9. Patients who have received major surgery or suffered severe trauma within 3 months before signing the informed consent, which the investigators judged would affect the postoperative pain evaluation, and/or experienced acute bleeding >= 400 ml; 10. Patients with Grade ? or above cardiac dysfunction (NYHA standard), ischemic heart disease (such as myocardial infarction or angina), clinically significant suprventricular or ventricular arrhythmias, and significant prolonged QTc interval (male >= 450 ms, female >= 470 ms) within 6 months prior to the signing of the informed consent were considered as additional risks for the study drugs; 11. Abnormal poorly controlled blood pressure within 3 months prior to signing the informed consent, and/or systolic blood pressure 180 mmHg and diastolic blood pressure > 110 mmHg; 12. Peripheral blood oxygen saturation (SpO2) was less than 92% in non-oxygenated condition; 13. Liver function: serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 1.5 times the upper limit of normal reference value (ULN), and/or total bilirubin > 1.5 x ULN, which the investigators judged to be clinically significant; 14. Renal function: Urea (Urea) > 1.5 x ULN and/or serum creatinine (Cr) > 1.5 x ULN, and/or serum creatinine clearance < the lower limit of normal value (LLN), and the investigators judged it had clinical significance; 15. Serum potassium and sodium ions in the screening period exceeded the normal value range, and were judged by the researchers to have clinical significance;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The summed pain intensity differences (SPID) within 24 hours (time-weighted); | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative use of remedial analgesics (morphine injection mg);Percentage of subjects not using remedial analgesics;The time from the end of laparoscopic abdominal surgery to the first use of remedial analgesic drugs in each group;Subjects' analgesic satisfaction scores; | — |
Countries
China
Contacts
Public ContactLiu jin
West China Hospital of Sichuan University
Outcome results
None listed