| Eligibility |
Inclusion Criteria:
1. Voluntarily signed informed consent form (ICF) and comply with the trial procedures
before starting the trial-related activities;
2. Aged 18-65 years (including the boundary value), male or female;
3. Body mass index (BMI) 18-29 kg/m2 (including the boundary value), male body weight =
50 kg; female body weight = 45 kg;
4. Subjects scheduled for elective abdominal surgery under general anesthesia, 1h =
duration of estimated surgery Interval = 4h;
5. American Society of Anesthesiologists(ASA )grade I ~ II;
6. Female subjects (not surgically sterile, surgical sterilization is defined as
hysterectomy or oophorectomy) with a negative pregnancy test at Screening. Male and
female subjects agree to take effective contraceptive measures throughout the study
and for at least 1 month after medication;
7. The investigator judges that the patient has recovered from intraoperative anesthesia
to enough awake, which can be accurately completed the questionnaire was specified,
and the numerical rating scale(NRS) score at rest was = 4 points within 4 hours after
surgery.
Exclusion Criteria:
1. Known history of allergy to any component of the investigational product, or allergy
or contraindication to the anesthetic/analgesic drugs used in the study;
2. Had any of the following conditions or medical history:
1. History of stroke, cognitive dysfunction, or epilepsy (excluding convulsions
caused by previous febrile convulsions in children);
2. History of difficult airway, such as obstructive sleep apnea syndrome, bronchial
asthma, chronic respiratory diseases or other serious respiratory diseases;
3. Subjects with a history of myocardial infarction, angina pectoris, severe
arrhythmia of degree II or above atrioventricular block, or New York Heart
Association(NYHA) Class II or above within 6 months prior to screening;
4. History of vestibular dysfunction or motion sickness;
5. Have a history of diabetes and glycosylated hemoglobin = 9% during the screening
period;
6. Esophagitis;
7. Paralytic gastrointestinal obstruction;
8. The presence of other acute and chronic pain conditions preoperatively or in
combination with other bodily pain conditions that confound the evaluation of
postoperative pain.
3. Medications affecting postoperative analgesia before randomization:
a) Opioid analgesics taken continuously for more than 10 days for any reason within 3
months prior to randomization, or taking opioid analgesics within 7 days prior to
randomization; b) Use of the following drugs within 14 days prior to randomization,
including but not limited to: ketamine, non-steroidal anti-inflammatory drugs
(aspirin, acetaminophen, indomethacin, diclofenac, ibuprofen, parecoxib sodium, etc.),
alpha adrenoceptor agonists (dexmedetomidine hydrochloride, clonidine, etc.),
glucocorticoids (dexamethasone hydrochloride, hydrocortisone, methylprednisolone,
etc., except for topical or topical use of glucocorticoids), antiepileptic drugs
(carbamazepine, sodium valproate, etc.), sedative drugs (diazepam, estazolam,
midazolam, alprazolam, barbiturate, phenobarbital and chloral hydrate, etc.); c) Use
of Chinese herbal medicine or Chinese patent medicine within 7 days prior to
randomization.
4. Systolic blood pressure less than 90 mmHg or greater than 160 mmHg and diastolic blood
pressure less than 1 day before surgery 60 mmHg or greater;
5. Peripheral saturation (SpO2) < 92% at screening or before administration;
6. corrected QT interval(QTc )> 450 ms for males and > 460 m for females at screening or
pre-dose ( QTc is expressed as Fridericia formula calculation);
7. Patients with abnormal liver and kidney function during screening period or before
administration: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >
1.5 times of normal value, total bilirubin higher than the upper limit of normal
value, serum creatinine (Cr) > 1.5 times of the upper limit of normal value during
screening period;
8. Subjects with coagulation abnormalities (PT prolonged more than 3 seconds above the
upper limit of normal and/or activated partial thromboplastin time(APTT) prolonged
more than 10 seconds above the upper limit of normal) during the screening period; and
the investigator confirmed that the abnormalities were clinically significant;
9. History of drug abuse or drug abuse before screening;
10. Positive result in screening of drugs of abuse via urinalysis;
11. Nursing mothers;
12. Positive hepatitis B virus surface antigen (HBsAg) test [but the subject is eligible
if the peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) is lower
than the lower limit of the reference range, and the investigator believes that the
subject is in a stable phase of chronic hepatitis B and will not increase the risk of
the subject]; hepatitis C virus (HCV) antibody, treponema pallidum antibody, human
immunodeficiency virus (HIV) antibody positive;
13. Participation in any medication (excluding vitamins and minerals) within 3 months
prior to informed consent Quality) Clinical trial personnel, except for those not
using investigational drugs;
14. subjects who are judged by the investigator to be not suitable for this clinical
trial, including but not limited to the presence of conditions that may confound the
interpretation of efficacy, safety, or tolerability data in this study.
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