NCT06170476
Completed
Not Applicable
A Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Finding Study of HSK21542 Injection for the Prevention of Postoperative Nausea and Vomiting (PONV)
Sichuan Provincial People's Hospital1 site in 1 country200 target enrollmentStarted: November 10, 2023Last updated:
ConditionsPostoperative Nausea and Vomiting
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sichuan Provincial People's Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Complete response
Overview
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled Dose-Finding study. About 200 subjects undergoing elective laparoscopic abdominal or gynecological surgery are planned to be enrolled and randomized into four groups by a ratio of 1:1:1:1.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Prior and concomitant diseases
- •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.
- •Prior and concomitant medications
- •Any of the following medications or treatments have been used at screening:
Arms & Interventions
HSK21542-60μg
Experimental
Intervention: HSK21542-60μg (Drug)
HSK21542-120μg
Experimental
Intervention: HSK21542-120μg (Drug)
HSK21542-180μg
Experimental
Intervention: HSK21542-180μg (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Complete response
Time Frame: 24 hours after the end of surgery
The primary efficacy analysis was the complete response (CR)within the 24 hours after the end of surgery (CR was defined as no vomiting or retching and on use of rescue medication)
Secondary Outcomes
- Proportion of subjects using rescue medication within 24 hours after the end of surgery(24 hours after the end of surgery)
- Proportion of subjects experiencing nausea within 24 hours after the end of surgery(24 hours after the end of surgery)
- Proportion of subjects experiencing significant nausea within 24 hours after the end of surgery(24 hours after the end of surgery)
- Proportion of subjects experiencing vomiting within 24 hours after the end of surgery(24 hours after the end of surgery)
- Time to first occurrence of vomiting or rescue therapy (whichever occurs first) within 24 hours after the end of surger(24 hours after the end of surgery)
- The cumulative morphine doses administered within 24 hours after the end of surgery(24 hours after the end of surgery)
- PONV Satisfaction Score by Subject and Investigator(24 hours after the end of surgery)
Investigators
Mengchang Yang
Deputy Chief Physician
Sichuan Provincial People's Hospital
Study Sites (1)
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