Efficacy and Safety of HSK21542 in Inducing Postoperative Analgesia in Undergoing Elective Laparoscopic Surgery
- Conditions
- Analgesia
- Registration Number
- NCT04424251
- Lead Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 124
Inclusion Criteria:<br><br> 1. 18 = age = 70 years old, with no gender requirement<br><br> 2. American Society of Anesthesiologists (ASA) Class I-II<br><br> 3. 18 kg/m^2 = BMI = 40 kg/m^2<br><br> 4. Subjects undergoing elective laparoscopic surgery under general anesthesia with an<br> expected surgery duration of 1-5 h (inclusive)<br><br> 5. Agree to participate in this trial and voluntarily sign the informed consent form;<br><br>Exclusion Criteria:<br><br> 1. History of allergy to opioids, such as urticaria, or allergic to the intraoperative<br> anesthetics prescribed in the protocol;<br><br> 2. History or evidence of any one of the following diseases prior to screening:<br><br> 1. History of cardiovascular diseases: Uncontrolled hypertension (systolic blood<br> pressure [SBP] = 170 mmHg and/or diastolic blood pressure [DBP] = 105 without<br> antihypertensive treatment, or SBP > 160 mmHg and/or DBP > 100 mmHg despite<br> antihypertensive treatment), aneurysm, severe arrhythmia, heart failure,<br> Adams-Stokes syndrome, New York Heart Association (NYHA) Class = III, severe<br> superior vena caval syndrome, pericardial effusion, acute myocardial ischemia,<br> unstable angina, myocardial infarction in the last 6 months before screening,<br> history of tachycardia/bradycardia requiring medication, and II-III degree<br> atrioventricular block (excluding patients with pacemakers);<br><br> 2. History of respiratory disorder: Severe chronic obstructive pulmonary disease,<br> acute exacerbation of chronic obstructive pulmonary disease, severe<br> bronchostenosis, throat mass, history of (bronchial) tracheoesophageal fistula<br> or airway tear, and severe respiratory tract infection in the last 2 weeks<br> before screening;<br><br> 3. History of disorders in the nervous and psychiatric system: History of<br> craniocerebral injury, possible convulsions, intracranial hypertension,<br> cerebral aneurysms, and history of cerebrovascular accidents; history of<br> schizophrenia, mania, mental aberration, long-term use of psychotropic drugs,<br> and cognitive disorder; history of depression, anxiety, and epilepsy, etc.;<br><br> 4. Underwent major surgery within 3 months before screening and was judged by the<br> investigator to have potential effect on the postoperative pain evaluation;<br><br> 3. Any of the following airway management risks during screening:<br><br> 1. Acute asthma attacks;<br><br> 2. Sleep apnea syndrome;<br><br> 3. History or family history of malignant hyperthermia;<br><br> 4. History of failed tracheal intubation;<br><br> 5. Difficult airway (modified Mallampati score = III) as determined by the<br> investigator;<br><br> 4. In receipt of any of the following drugs or therapies during the screening period:<br><br> 1. The time between randomization and the last dose of opioid or non-opioid (such<br> as acetaminophen, aspirin [daily dose of > 100 mg], indomethacin, diclofenac,<br> parecoxib sodium and other non-steroidal anti-inflammatory drugs) analgesics is<br> shorter than 5 half-lives of the drug or the duration of drug efficacy<br> (whichever is longer);<br><br> 2. Continuous use of opioid analgesics for more than 10 days for any reason within<br> 3 months before screening;<br><br> 3. Use of drugs that affect the analgesic effect within 14 days before<br> randomization, including but not limited to: Sedative hypnotics<br> (benzodiazepines [triazolam, diazepam, midazolam, etc.], non-benzodiazepines<br> [zolpidem, zopiclone, zaleplon, etc.]), sedative anesthetics (sevoflurane,<br> anesthesia ether, nitrous oxide, thiopental, ketamine, etomidate, etc.),<br> glucocorticoids (dexamethasone hydrochloride , methylprednisolone, etc.),<br> anti-epilepsy drugs (carbamazepine, sodium valproate, etc.), anxiolytics<br> (carbamazepine, diazepam, etc.), antidepressants (imipramine, amitriptyline,<br> etc.), and Chinese herbal medicines or Chinese patent medicines with analgesic<br> and sedative effects;<br><br> 4. Expected to receive anti-tumor drugs and treatments during the period from 14<br> days before randomization to the end of the follow-up period, including but not<br> limited to chemotherapeutic drugs, targeted drugs, and Chinese herbal<br> medicines.<br><br> 5. The time between randomization and the last use of diuretics and compound drugs<br> containing diuretic components is shorter than 5 half-lives of the drug or the<br> duration of drug efficacy (whichever is longer);<br><br> 5. Laboratory test parameters meet one of the following criteria in the screening<br> period and is confirmed by retests:<br><br> 1. White blood cell count < 3.0 x 10^9/L;<br><br> 2. Platelet count < 80 x 10^9/L;<br><br> 3. Hemoglobin <70 g/L;<br><br> 4. Prothrombin time > 1.5 x ULN;<br><br> 5. Activated partial thromboplastin time > 1.5 x ULN;<br><br> 6. Alanine aminotransferase and/or aspartate aminotransferase > 2 x ULN;<br><br> 7. Total bilirubin > 1.5 x ULN;<br><br> 8. Blood creatinine > 1.5 x ULN;<br><br> 9. Fasting blood glucose = 11.1 mmol/L;<br><br> 6. Without oxygen supplement during the screening period, the pulse oxygen saturation<br> is < 92%;<br><br> 7. During the screening period, the virological examination for hepatitis B surface<br> antigen (HBsAg), hepatitis C antibody (HCVAb), treponema pallidum antibody, or human<br> immunodeficiency virus (HIV) antibody is positive;<br><br> 8. History of drug abuse, narcotics use and/or alcohol abuse within 3 months before<br> screening. Alcohol abuse is defined as > 2 units of alcohol consumption per day (1<br> unit = 360 mL of beer containing 5% alcohol, 45 mL of liquor containing 40% alcohol,<br> or 150 mL of wine);<br><br> 9. Donated or lost = 400 mL of blood within 3 months before screening;<br><br> 10. Participated in any drug clinical trials within 3 months before screening (defined<br> as the administration of the investigational product or placebo);<br><br> 11. Women who are pregnant or breastfeeding; fertile women or men who are unwilling to<br> use contraception during the trial; subjects who are planning pregnancy within 3<br> month after the completion of the trial (including male subjects);<br><br> 12. Subjects determined by the investigator to be unsuitable for participating in this<br> clinical study for any other reason.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sum of Pain Intensity Differences (SPID)
- Secondary Outcome Measures
Name Time Method Sum of Pain Intensity Differences (SPID);Use of remedial analgesics;Pain Intensity Differences(PID);The proportion of subjects with a NRS of = 3;Duration of analgesia;Satisfaction scores on postoperative analgesia