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

An Economic Study on Prevention of Postoperative Nausea and Vomiting by HSK21542 Injection

This study analyzed the efficacy and safety results of HSK21542 injection for the prevention of postoperative nausea and vomiting in a multicentre, randomized, double-blind, placebo-controlled dose-exploration study, as well as the real-world clinical routine use of troisisone and other (not limited to other setron drugs) for the prevention of postoperative nausea and vomiting and related adverse reaction treatment data. It was transformed into an effect indicator, and the possible costs involved in the study were analyzed, reasonable price parameters of HSK21542 injection were set, and the economic value of HSK21542 was explored.

Study Overview

• Status: Recruiting
• Conditions: Nausea and Vomiting, Postoperative
• Intervention / Treatment: Drug: Placebo; Drug: HSK21542

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mengchang Yang, Doctor; Phone Number: +8618140049936; Email: ymc681@126.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Sichuan Provincial People's Hospital
      • Sub-Investigator: Lina Yang
      • Contact: Mengchang Yang, Doctor; Phone Number: +8618140049936; Email: ymc681@126.com
      • Principal Investigator: Mengchang Yang
      • Sub-Investigator: Yu He
      • Sub-Investigator: Mengxia Lan
      • Sub-Investigator: Ai Wei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HSK21542-60μg; HSK21542 injection of 60 μg was administered once within 15 min before the end of surgery, and was administered by intravenous bolus injection for no less than 30 s;	Drug: HSK21542; This study is an economic study and does not interfere with patients' medical treatment.
Experimental: HSK21542-120μg; HSK21542 injection of 120 μg was administered once within 15 min before the end of surgery, and was administered by intravenous bolus injection for no less than 30 s;	Drug: HSK21542; This study is an economic study and does not interfere with patients' medical treatment.
Experimental: HSK21542-180μg; HSK21542 injection of 180 μg was administered once within 15 min before the end of surgery, and was administered by intravenous bolus injection for no less than 30 s;	Drug: HSK21542; This study is an economic study and does not interfere with patients' medical treatment.
Placebo Comparator: Placebo; A placebo was administered once within 15 min before the end of surgery, and was administered by intravenous bolus injection for no less than 30 s;	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total direct medical costs, direct non-medical costs, indirect costs	24 hours after the end of surgery

Collaborators and Investigators

• Sponsor: Mengchang Yang
• Investigators: Principal Investigator: Mengchang Yang, Doctor, Prinipal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2024
• Primary Completion (Estimated): November 6, 2024
• Study Completion (Estimated): November 6, 2024

Study Registration Dates

• First Submitted: December 25, 2023
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: HSK21542-IIT-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Plan to publish articles to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No