Postoperative pain
Conditions
Interventions
SHR0410 Injection Group A:Intravenous administration of A dose of SHR0410 injection
SHR0410 Injection Group B:Intravenous administration of B dose of SHR0410 injection
Placebo Control Group:Administration of intravenous Placebo
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Before starting the trial-related activities, voluntarily sign the informed consent form, fully understand the purpose and significance of the trial, and voluntarily abide by the trial process; 2. Subjects who elect to undergo laparoscopic surgery under general anesthesia; the expected duration of surgery is >=1h; 3. The American Society of Anesthesiologists (ASA) is graded I to II; 4. Age >= 18 years old, no gender restrictions; 5. 18kg/m2= 4 points; 7. There were no plans to donate sperm or have a child 30 days before the screening period and 30 days after the last dose, and both subjects and their partners agreed to use medically approved highly effective contraception during the trial period and 30 days after the last dose (see Annex 9). 8. Female subjects who were not menopausal or had been menopausal for less than two years should have a negative blood pregnancy test within 7 days before study entry and were not lactating.
Exclusion criteria
Exclusion criteria: 1. Dizziness, nausea, retching, vomiting or combined vestibular dysfunction within 1 week before screening; 2. Subjects with a history of new myocardial infarction or unstable angina, a history of severe arrhythmias such as atrioventricular block of grade II or higher, or a history of NYHA class III or higher heart function within 6 months before screening; 3. Diagnosed with refractory hypertension or a history of refractory hypertension (see Annex 10 for details); 4. Past history of stroke; 5. Cognitive dysfunction in the past, or a history of epilepsy; 6. History of difficult airway, such as obstructive sleep apnea syndrome; 7. Combined with other physical pain conditions that confound postoperative pain evaluation; 8. Systolic blood pressure 3.0 times the upper limit of normal, total bilirubin (TBIL) >1.5 times the upper limit of normal, serum creatinine (Cr) during the screening period >1.5 times the upper limit of normal; 10. Venous potassium (K+) normal during the screening period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS pain intensity scale;Pain Relief Score;Electrocardiogram (ECG);Heart rate, pulse;blood pressure;pharmacodynamics;SpO2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaire on satisfaction ; | — |
Countries
China
Contacts
Public ContactWen Ouyang
Outcome results
None listed