Postoperative Nausea and VomitingNCT06170476
A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in PONV
A study testing HSK21542-60μg, HSK21542-120μg and HSK21542-180μg in people with Postoperative Nausea and Vomiting, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- HSK21542-60μg, HSK21542-120μg and HSK21542-180μg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2023to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- 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;
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- 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:
- 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 and other tests
- 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;
- Other conditions
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Finding Study of HSK21542 Injection for the Prevention of Postoperative Nausea and Vomiting (PONV)
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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- HSK21542-60μg, HSK21542-120μg, HSK21542-180μg, Placebo
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK21542-60μgDrug
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;
HSK21542-120μgDrug
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;
HSK21542-180μgDrug
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;
PlaceboDrug
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;
| Study group | Role | What they receive |
|---|---|---|
| HSK21542-60μg | Experimental | Not described Receives: Drug: HSK21542-60μg |
| HSK21542-120μg | Experimental | Not described Receives: Drug: HSK21542-120μg |
| HSK21542-180μg | Experimental | Not described Receives: Drug: HSK21542-180μg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response
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)
Measured: 24 hours after the end of surgery
Secondary outcomes (7)
Proportion of subjects experiencing nausea within 24 hours after the end of surgery
Nausea (defined as a feeling of urgency to vomit, characterized by merycism and/or urgent vomiting) measured on a 0-10 verbal response scale[VAS], where 0=no nausea at all and 10=the worst nausea that cannot be tolerated
Measured: 24 hours after the end of surgery
Proportion of subjects experiencing significant nausea within 24 hours after the end of surgery
Significant nausea is defined as VAS score ≥ 4 cm
Measured: 24 hours after the end of surgery
Proportion of subjects experiencing vomiting within 24 hours after the end of surgery
vomiting [even with the expulsion of scanty gastric contents] or retching [presence of vomiting muscle movement without the expulsion of gastric contents])
Measured: 24 hours after the end of surgery
Proportion of subjects using rescue medication within 24 hours after the end of surgery
Any drug given in the post-operative period with the intention of providing anti-emetic rescue is counted as rescue anti-emetic medication
Measured: 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
Vomiting includes vomiting or retching
Measured: 24 hours after the end of surgery
The cumulative morphine doses administered within 24 hours after the end of surgery
Morphine as the postoperative analgesics
Measured: 24 hours after the end of surgery
PONV Satisfaction Score by Subject and Investigator
Satisfaction Score rating range 0-10,where 0=not satisfactory at all, and 10=the most satisfactory
Measured: 24 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start10 Nov 2023
- Primary completion28 Feb 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mengchang Yang, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170476
- Sponsor's protocol ID
- HSK21542-IIT-01
- Status last verified
- Jul 2024
- First submitted
- 6 Dec 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Finding Study of HSK21542 Injection for the Prevention of Postoperative Nausea and Vomiting (PONV)
- ClinicalTrials.gov ID
- NCT06170476
- Acronym / sponsor ID
- HSK21542-IIT-01
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HSK21542-60μg | Experimental | Drug: HSK21542-60μg |
| HSK21542-120μg | Experimental | Drug: HSK21542-120μg |
| HSK21542-180μg | Experimental | Drug: HSK21542-180μg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (32 listed)
- Prior and concomitant diseases
- History or evidence of any of the following diseases prior to screening:
- Prior and concomitant medications
- Any of the following medications or treatments have been used at screening:
- Laboratory and other tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK21542-60μgHSK21542 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 | HSK21542-60μg |
| HSK21542-120μgHSK21542 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 | HSK21542-120μg |
| HSK21542-180μgHSK21542 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 | HSK21542-180μg |
| PlaceboA 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 |
Primary outcome
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)
7 secondary outcomes
Proportion of subjects experiencing nausea within 24 hours after the end of surgery
Time frame: 24 hours after the end of surgery
Proportion of subjects experiencing significant nausea within 24 hours after the end of surgery
Time frame: 24 hours after the end of surgery
Proportion of subjects experiencing vomiting within 24 hours after the end of surgery
Time frame: 24 hours after the end of surgery
Proportion of subjects using rescue medication within 24 hours after the end of surgery
Time frame: 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
Time frame: 24 hours after the end of surgery
The cumulative morphine doses administered within 24 hours after the end of surgery
Time frame: 24 hours after the end of surgery
PONV Satisfaction Score by Subject and Investigator
Time frame: 24 hours after the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HSK21542-60μg, HSK21542-120μg and HSK21542-180μg in people with Postoperative Nausea and Vomiting, run by Sichuan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (time frame: 24 hours after the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.