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 0.35mg (1ml)
Group 2: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. Understand the trial, understand and can cooperate with the process of the trial, voluntarily participate in and sign the written informed consent; 2. 18 years old< = age< = 75 years old, gender is not limited; 3. 18.0 kg/m^2<=body mass index (BMI)<=28.0 kg/m^2; 4. American Society of Anesthesiologists (ASA) Classification I ~ II (Appendix 1); 5. Subjects undergoing abdominal surgery under elective general anesthesia, 1 h<=estimated duration of surgery= 6 h; 6. The investigator judged that the subject had recovered from intraoperative anesthesia to be awake enough to accurately complete the protocol prescribed scale, and the pain score of the Numeric Rating Scale (NRS) at rest within 4 hours after surgery was = 4 points.
Exclusion criteria
Exclusion criteria: 1. Those who are known to have a history of allergy to opioids or any component of the investigational drug, or those who are allergic to the drugs and excipients used in this study; 2. Have the following diseases or medical history: a. Central nervous system: cognitive impairment, history of epilepsy (excluding previous convulsions caused by febrile convulsions in children), Parkinson's, increased intracranial pressure, head injury or head tumor, cerebral hemorrhage/cerebral infarction with language, emotion, and limb dysfunction; b. Comorbid psychiatric disorders, such as anxiety disorder, schizophrenia, depression, etc.; c. History of myocardial infarction, unstable angina, or severe arrhythmia such as second-degree and above atrioventricular block within 6 months prior to signing the informed consent, New York Heart Association (NYHA) cardiac function classification (Appendix 2) grade II or above; d. History of difficult airway, obstructive sleep apnea-hypopnea syndrome, menstruation Those with respiratory diseases judged by the investigator to be unsuitable for enrollment, or those with acute upper respiratory tract infection within 2 weeks before admission to the operating room, which are judged by the investigator to be unsuitable for enrollment; e. Patients with a blood glucose = 11.1mmol/L during the screening period (until admission to the operating room) (randomized), or diabetic patients with poor glycemic control (glycosylated hemoglobin =9%); f. Patients with a previous definite diagnosis of reflux esophagitis and non-foodborne nausea and vomiting within 1 month before signing the informed consent form, or a definite diagnosis of gastrointestinal obstruction (excluding the obstruction caused by the disease to be treated this time) within 12 months before signing the informed consent form; g. Those who have undergone surgery within 3 months prior to signing the informed consent form that may significantly affect the in vivo metabolism or safety evaluation of the experimental drug; h. Patients with other episodes of acute and chronic pain (including neuralgia) that are not related to the disease of this operation within 1 month before signing the informed consent, and who, in the opinion of the investigator, may confound the postoperative pain assessment; 3. Patients with systolic blood pressure > 160 mmHg and/or diastolic > 100 mmHg, or systolic blood pressure 1.5 times the upper limit of the reference value, or the upper limit of the total bilirubin > the reference value, or the blood creatinine (Cr) > 1.5 times the upper limit of the reference value; b. Prothrombin time (PT) prolongation > upper limit of reference value by 3 seconds and/or activated partial thromboplastin time (APTT) prolongation > upper limit of reference value by 10 seconds; 6. Those who have positive urine drug screening results during the screening period (before entering the operating room); 7. Those who have participated in any clinical trial of drugs (excluding vitamins and minerals) within 1 month before signing the informed consent form and hav
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Summed pain intensity difference (SPID) at rest over the 24-hour postdose period (SPID24); | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS pain intensity scale;Pain Relief Score;SPID6, SPID12, SPID18, SPID12-24 in the resting state;SPID6, SPID12, SPID18, SPID12-24, SPID24 during movement;Ramsay sedation scale;Risk score for postoperative nausea and vomiting (PONV) in adults;Subject satisfaction score;Pharmacokinetics;Time to first pain relief; | — |
Countries
China
Contacts
Public ContactWen Ouyang / Saiying Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed