| Eligibility |
Inclusion Criteria:
1. 18 = age = 65 years old, with no gender requirement
2. American Society of Anesthesiologists (ASA) Class I-II
3. 18 kg/m^2 = BMI = 30 kg/m^2
4. Subjects undergoing elective laparoscopic surgery under general anesthesia with an
expected surgery duration of 1-5 h (inclusive)
5. Agree to participate in this trial and voluntarily sign the informed consent form;
Exclusion Criteria:
1. History of allergy to opioids, such as urticaria, or allergic to the intraoperative
anesthetics prescribed in the protocol;
2. History or evidence of any one of the following diseases prior to screening:
1. History of cardiovascular diseases: Uncontrolled hypertension (systolic blood
pressure [SBP] = 170 mmHg and/or diastolic blood pressure [DBP] = 105 without
antihypertensive treatment, or SBP > 160 mmHg and/or DBP > 100 mmHg despite
antihypertensive treatment), aneurysm, severe arrhythmia, heart failure,
Adams-Stokes syndrome, New York Heart Association (NYHA) Class = III, severe
superior vena caval syndrome, pericardial effusion, acute myocardial ischemia,
unstable angina, myocardial infarction in the last 6 months before screening,
history of tachycardia/bradycardia requiring medication, and II-III degree
atrioventricular block (excluding patients with pacemakers);
2. History of respiratory disorder: Severe chronic obstructive pulmonary disease,
acute exacerbation of chronic obstructive pulmonary disease, severe
bronchostenosis, throat mass, history of (bronchial) tracheoesophageal fistula or
airway tear, and severe respiratory tract infection in the last 2 weeks before
screening;
3. History of disorders in the nervous and psychiatric system: History of
craniocerebral injury, possible convulsions, intracranial hypertension, cerebral
aneurysms, and history of cerebrovascular accidents; history of schizophrenia,
mania, mental aberration, long-term use of psychotropic drugs, and cognitive
disorder; history of depression, anxiety, and epilepsy, etc.;
4. Underwent major surgery within 3 months before screening and was judged by the
investigator to have potential effect on the postoperative pain evaluation;
3. Any of the following airway management risks during screening:
1. Acute asthma attacks;
2. Sleep apnea syndrome;
3. History or family history of malignant hyperthermia;
4. History of failed tracheal intubation;
5. Difficult airway (modified Mallampati score = III) as determined by the
investigator;
4. In receipt of any of the following drugs or therapies during the screening period:
1. The time between randomization and the last dose of opioid or non-opioid (such as
acetaminophen, aspirin [daily dose of > 100 mg], indomethacin, diclofenac,
parecoxib sodium and other non-steroidal anti-inflammatory drugs) analgesics is
shorter than 5 half-lives of the drug or the duration of drug efficacy (whichever
is longer);
2. Continuous use of opioid analgesics for more than 10 days for any reason within 3
months before screening;
3. Use of drugs that affect the analgesic effect within 14 days before
randomization, including but not limited to: Sedative hypnotics (benzodiazepines
[triazolam, diazepam, midazolam, etc.], non-benzodiazepines [zolpidem, zopiclone,
zaleplon, etc.]), sedative anesthetics (sevoflurane, anesthesia ether, nitrous
oxide, thiopental, ketamine, etomidate, etc.), glucocorticoids (dexamethasone
hydrochloride , methylprednisolone, etc.), anti-epilepsy drugs (carbamazepine,
sodium valproate, etc.), anxiolytics (carbamazepine, diazepam, etc.),
antidepressants (imipramine, amitriptyline, etc.), and Chinese herbal medicines
or Chinese patent medicines with analgesic and sedative effects;
4. Expected to receive anti-tumor drugs and treatments during the period from 14
days before randomization to the end of the follow-up period, including but not
limited to chemotherapeutic drugs, targeted drugs, and Chinese herbal medicines.
5. The time between randomization and the last use of diuretics and compound drugs
containing diuretic components is shorter than 5 half-lives of the drug or the
duration of drug efficacy (whichever is longer);
5. Laboratory test parameters meet one of the following criteria in the screening period
and is confirmed by retests:
1. White blood cell count < 3.0 x 10^9/L;
2. Platelet count < 80 x 10^9/L;
3. Hemoglobin < 80 g/L;
4. Prothrombin time > 1.5 x ULN;
5. Activated partial thromboplastin time > 1.5 x ULN;
6. Alanine aminotransferase and/or aspartate aminotransferase > 2 x ULN;
7. Total bilirubin > 1.5 x ULN;
8. Blood creatinine > 1.5 x ULN;
9. Fasting blood glucose = 11.1 mmol/L;
6. Without oxygen supplement during the screening period, the pulse oxygen saturation is
< 92%;
7. During the screening period, the virological examination for hepatitis B surface
antigen (HBsAg), hepatitis C antibody (HCVAb), treponema pallidum antibody, or human
immunodeficiency virus (HIV) antibody is positive;
8. History of drug abuse, narcotics use and/or alcohol abuse within 3 months before
screening. Alcohol abuse is defined as > 2 units of alcohol consumption per day (1
unit = 360 mL of beer containing 5% alcohol, 45 mL of liquor containing 40% alcohol,
or 150 mL of wine);
9. Donated or lost = 400 mL of blood within 3 months before screening;
10. Participated in any drug clinical trials within 3 months before screening (defined as
the administration of the investigational product or placebo);
11. Women who are pregnant or breastfeeding; fertile women or men who are unwilling to use
contraception during the trial; subjects who are planning pregnancy within 3 month
after the completion of the trial (including male subjects);
12. Subjects determined by the investigator to be unsuitable for participating in this
clinical study for any other reason.
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