Postoperative pain
Conditions
Interventions
Group 1:YZJ-4729 was administered intravenously as a loading dose of 1.5mg(5ml) and PCA as a single dose of 0.2mg(1ml)
Group 2:YZJ-4729 was administered intravenously as a loading dose of 1.5mg(5ml) and PCA as a single dose of 0.35mg(1ml)
Group 3:YZJ-4729 was administered intravenously as a loading dose of 1.5mg(5ml) and PCA as a single dose of 0.5mg(1ml)
Group 4:YZJ-4729 was administered intravenously as a loading dose of 2.0mg(5ml) and PCA as a single dose of 0.35mg(1ml)
Positive control group:Morphine was administered intravenously as a loading dose of 3.0mg(5ml) and PCA as a single dose of 1.0mg(1ml)
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) 18 years old = age =75 years old, regardless of gender; 2) 18.0 kg/m2= body mass index (BMI)=28.0 kg/m2; 3) American Society of Anesthesiologists (ASA) grade I to II (Appendix 1); 4) for elective abdominal surgery under general anesthesia, 1h= expected duration of surgery = 6 h; 5) The investigator judged that the patient had recovered sufficiently from intraoperative anesthesia to accurately complete the protocol questionnaire. The postoperative pain intensity was defined as moderate to severe pain, which was defined as NRS pain score =4 in the resting state within 4 hours after extubation; 6) fully understand and voluntarily participate in this study, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) patients with a known history of allergy to any component of the investigational drug, or allergy to or contraindication to anesthetic/analgesic drugs used in surgery; 2) Have the following diseases or medical history: a) a history of stroke, parkinsonism, cognitive impairment, or epilepsy (excluding previous convulsions caused by febrile seizures in children); b) patients with head injury, intracranial lesions, increased intracranial pressure or brain tumors; c) a history of difficult airway, such as obstructive sleep apnea syndrome, bronchial asthma, chronic respiratory disease, other severe respiratory disease or acute upper respiratory tract infection within 2 weeks; d) a history of myocardial infarction, angina, or severe arrhythmia such as atrioventricular block of degree II or higher, with a history of New York Heart Association (NYHA) functional class II or higher (Appendix 2) within 6 months before screening; e) patients with a history of vestibular dysfunction or motion sickness, or dizziness, nausea, retching/vomiting within 1 week before screening; f) concurrent gastrointestinal motility disorders (e.g., reflux esophagitis) or known/suspected GI obstruction, including paralytic GI obstruction; g) a history of diabetes with a glycated hemoglobin A1c =9% at screening; h) patients with hypothyroidism; i) the presence of other acute or chronic pain conditions before surgery or other physical pain conditions that conflate postoperative pain assessment; 3) untreated or poorly controlled hypertension with treatment: systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg during screening (excluding abnormalities during peri-anesthesia period); 4) Systolic blood pressure less than 90mmHg during the screening period (excluding abnormal results during peri-anesthesia period); 5) transcutaneous oxygen saturation (SpO2)< during screening; 92%(excluding peri-anesthesia abnormalities); 6) QTc> in screening males; 450 ms, QTc> in women; 470 ms; 7) patients with abnormal liver and kidney function during screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 1.5 times the upper limit of normal, total bilirubin higher than the upper limit of normal, serum creatinine (Cr)> 1.5 times the upper limit of normal; 8) patients with abnormal coagulation function during screening: prothrombin time (PT) prolongation exceeding 3 seconds and/or activated partial thromboplastin time (APTT) prolongation exceeding 10 seconds; 9) positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody, and human immunodeficiency virus antibody (HIV-Ab); 10) use of drugs that affect postoperative analgesia before randomization: a) opioid analgesic use for any reason for more than 10 consecutive days within 3 months before randomization, or within 5 half-lives before randomization; b) The use of the following drugs within 14 days before randomization, including but not limited to: ketamine, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin allowed for cardiovascular prevention, provided that it had been used stably for at least 30 days before randomization, Daily dose =100mg/ day), a2-adrenoceptor agonists, glucocorticoids (except topical), antiepileptic drugs, sedatives; c) use of analgesic Chinese herbal medicine or Chinese patent medicine within 7 days before randomization; 11) monoamine oxidase inhibitors (phenelzine, cyclopropylamine, selagiline, pargyline,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS pain intensity scale;Summed pain intensity difference (SPID); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain Relief Score;Subject satisfaction score;Researchers satisfaction score;Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactWen Ouyang / Saiying Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed