An Economic Study of HSK21542 Injection for Prevention of Postoperative Nausea and Vomiting

Launched by MENGCHANG YANG · Apr 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new injection called HSK21542, which aims to prevent nausea and vomiting that can occur after surgery. The study is looking to see how well this injection works and how safe it is for patients undergoing elective laparoscopic surgeries, such as abdominal or gynecological procedures. Participants in the trial will be randomly assigned to receive either the HSK21542 injection or a placebo (a treatment that looks the same but has no active medication) to compare the effects. Researchers will also explore the costs associated with using HSK21542 and its overall value in preventing postoperative nausea and vomiting.

To be eligible for this trial, participants need to be between 18 and 75 years old, scheduled for a specific type of surgery, and at intermediate or high risk for nausea and vomiting after surgery. Individuals with certain health conditions, including severe respiratory or cardiovascular issues, and those who have taken certain medications recently, may not qualify. If you decide to participate, you can expect to be monitored for any side effects and the effectiveness of the treatment during your recovery. Your involvement will help researchers understand if HSK21542 could be a beneficial option for managing nausea and vomiting after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 and ≤75 years old, male or female;
• • The American Society of Anesthesiologists (ASA) Class I-III;
• • 18 kg/m2 ≤ BMI ≤ 40 kg/m2;
• • Hospitalized subjects scheduled to undergo elective laparoscopic abdominal or gynecological surgery under general anesthesia for an expected anesthetic time of ≥ 1 h;
• • Subjects with intermediate or high risk (score ≥ 2 points) experiencing PONV judged by the investigator using the Apfel simplified risk score;
• • Subjects who agree to participate in the trial and voluntarily sign the Informed Consent Form (ICF);
• Exclusion Criteria:
• • History or evidence of any of the following diseases prior to screening:Respiratory diseases: severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, large pharyngolaryngeal mass, (broncho) tracheoesophageal fistula or airway tear, and serious respiratory tract infection within 2 weeks prior to screening; Central nervous system disorders: subjects with epilepsy, Parkinson's disease, or other central nervous system diseases causing nausea and vomiting, such as craniocerebral injury, intracranial space-occupying lesions, intracranial aneurysms, etc.; Cardiovascular diseases: subjects with uncontrolled hypertension \[systolic blood pressure (SBP) ≥170 mmHg and/or diastolic blood pressure (DBP) ≥105 mmHg without treatment with antihypertensive medication, or SBP ≥160 mmHg and/or DBP ≥100 mmHg after treatment with antihypertensive medications\], serious cardiac insufficiency ( the New York Heart Association \[NYHA\] Grade III-IV), unstable angina pectoris, acute myocardial infarction, severe arrhythmia, history of tachycardia/bradycardia requiring medical treatment, Grade II-III atrioventricular block (excluding pacemaker use) within 6 months prior to screenin; Digestive disorders: subjects with intestinal obstruction or other digestive diseases that may cause nausea and vomiting as judged by the investigator; Patients with a confirmed diagnosis of vestibular function disorder, excluding travel sickness (including but not limited to peripheral vestibular syndrome, central vestibular syndrome, etc.); Subjects with a history of significant and chronic dizziness.
• • Any of the following medications or treatments have been used at screening:Subjects who have received antiemetics/medications with antiemetic effects within 24 h before the start of surgery or who have used antiemetics/drugs with antiemetic effects before the start of surgery for no more than 5 half-lives (calculated as the longest time); Subjects with neoplasm malignant treated with chemotherapy within 4 weeks prior to screening;
• • Laboratory test indicators at screening meet the following criteria:White blood cell count \< 3.0 × 109/L;Platelet count \< 80 × 109/L;Hemoglobin\< 70 g/L;Prolongation of prothrombin time (PT) exceeding the upper limit of normal for 3 seconds;Prolongation of activated partial thromboplastin time (APTT) exceeding the upper limit of normal for 10 seconds;Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 3 × ULN;Total bilirubin \> 2 × ULN;Blood creatinine \> 2 × ULN;Fasting serum glucose≥ 11.1 mmol/L;
• • Subjects anticipated to require continued endotracheal intubation after the end of surgery;
• • Subjects anticipated to require the insertion of nasal or oral gastric tubes after the end of surgery;
• • Subjects with a history of serious drug allergies or those allergic to the investigational drugs specified in the protocol;
• • Subjects with a history of drug abuse, drug addiction, or alcoholism within 3 months prior to screening, where alcoholism is defined as consuming \> 2 units of alcohol on average daily (1 unit = 360 mL of beer with 5% alcohol, 45 mL of liquor with 40% alcohol or 150 mL of wine);
• • Subjects with nausea, retching, or vomiting within 24 h prior to induction of anesthesia (except for those caused by bowel preparation);
• • Subjects who have participated in any investigational trial (defined as receiving investigational drug or placebo) within 3 months prior to screening;
• • Female subjects who are pregnant or breastfeeding; female or male subjects of child-bearing potential are unwilling to use contraception throughout the entire study period and for 3 months after the study completion;
• • Subjects judged by the investigator to be unsuitable for participating in this clinical trial for any other factors.