ClinicalTrials.gg
Status unknownNCT05822713Updated Apr 21, 2023

A Comparison of the Efficacy of Amisulpride and Placebo in the Prevention of PONV in Patients at Moderate-to-high Risk of PONV.

A Phase 3 interventional study of Amisulpride and Amisulpride Placebo in PONV, sponsored by Qilu Pharmaceutical (Hainan) Co., Ltd.. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-21.

Sponsored by Qilu Pharmaceutical (Hainan) Co., Ltd. (part of Qilu Pharmaceutical Co., Ltd.) · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
516
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

A comparison of the efficacy of Amisulpride and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.

02

Conditions studied

03

In context

Postoperative Nausea and Vomiting

638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.

This study's planned enrollment of 516 is above the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.

Browse Postoperative Nausea and Vomiting studies →

Lead sponsor

Qilu Pharmaceutical (Hainan) Co., Ltd. is the lead sponsor of 8 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

Inclusion Criteria:

  1. Participant understand the study procedures and methods, voluntarily participate in this trial, and sign the .
  2. Male or female patients ≥ 18 years of age and ≤75 years of age.
  3. 18\<≤30kg/m\^2,And weigh more than 45kg
  4. Patients undergoing elective surgery(laparoscopic gynecological or abdominal surgery) under general anaesthesia requiring,and inhalation anesthesia is maintained for more than 1 hour, but patients who receive purely diagnostic surgery cannot be enrolled;
  5. Patients with at least 2 of the following risk factors for PONV:

    Past history of PONV and/or motion sickness Habitual non-smoking status Female sex Expected to receive opioid analgesia post-operatively

  6. (ASA) risk score I-III -

Exclusion Criteria:

  1. Patients undergoing day case surgery
  2. Patients undergoing intra-thoracic, transplant or central nervous system surgery or any surgery where post-operative emesis may pose a significant danger to the patient
  3. Patients planned to receive only a local anaesthetic and/or regional neuraxial (intrathecal or epidural) block
  4. Patients who are scheduled to be transferred to the ICU after surgery;
  5. Patients who are expected to need a naso- or oral-gastric tube in situ after surgery is completed
  6. Patients who have a documented, cardiac arrhythmia or congenital long syndrome(Male≥ 450 ms female≥ 460ms).
  7. Adequate hepatic and renal function, (ALT) and/or aspartate aminotransferase (AST) ≥ 2.5 x upper limit normal (), ≥ 1.5 x ULN,Creatinine ≥ 1.5x ULN
  8. Patients who have received Amisulpride active ingredient for any indication within the last 2 weeks
  9. Patients who are allergic to Amisulpride active ingredient or any of the of Amisulpride
  10. Patients with a significant, ongoing history of vestibular disease or dizziness
  11. Intestinal obstruction
  12. Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or breast cancer) or phaeochromocytoma.
  13. Patients with pre-existing nausea or vomiting in the 24 hours before surgery
  14. Patients treated with regular anti-emetic therapy including
  15. Patients being treated with medications which could induce torsades de pointes, including Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide; Class III antiarrhythmic agents such as amiodarone and sotalol; and other medications such as bepridil, cisapride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin
  16. Patients being treated with levodopa or other dopamine drugs
  17. Patients who are pregnant or breast feeding.
  18. Participant who has a history of drug or alcohol abuse within 6 months before randomization
  19. Patients diagnosed with Parkinson's disease ,Patients with a history of epilepsy.
  20. Patients who have received anti-cancer chemotherapy in the previous 4 weeks of surgery
  21. Patients who have participated in other clinical research trials within 3 months before randomization
  22. Participant who may increase study-related risks or interfere with the interpretation of study results in the opinion of the investigator, who are considered unsuitable for enrollment by the investigator and/or the sponsor.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
516 participants (estimated)

Study arms

  • Experimental
    Experimental

    Amisulpride at 5mg was given by slow iv administration during1 to 2 min at induction of anesthesia

    Drug: Amisulpride

  • Placebo comparator
    Placebo

    Placebo was given by slow iv administration during1 to 2 min at induction of anesthesia

    Drug: Amisulpride Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. The primary endpoint was the composite measure complete response

    defined as no episodes of emesis (vomiting or retching) and no use of rescue medication in the first 24h after wound closure

    Time frame: 24 hours after the end of surgery

Secondary outcomes

  1. Incidence of no Nausea

    Count of patients experiencing an episode of no nausea scored \< 1 of 0-10 verbal response scale during the 24 hours period after the completion of surgery

    Time frame: 24 hours after end of surgery

  2. Incidence of moderate and severe Nausea

    Count of participants with nausea score \> 4 on 0-10 verbal response scale

    Time frame: 24 hours after end of surgery

  3. Incidence of Emesis (Vomiting/Retching)

    An assessment of a participant experiencing an episode of emesis (vomiting/ retching) during the 24hours after the completion of the surgery

    Time frame: 24 hours after end of surgery

  4. Use of Rescue Medication

    Time frame: 24 hours after end of surgery

  5. Time to First Violation of Criteria for PONV

    Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery

    Time frame: 24 hours after end of surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2023; primary completion for Aug 2023, 4 months later.

Of 22 phase 3 interventional studies under Postoperative Nausea and Vomiting, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2023
First posted
Apr 21, 2023
StartEst.
Apr 29, 2023
Primary completionEst.
Aug 31, 2023
CompletionEst.
Dec 31, 2023
Last update
Apr 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05822713
Responsible party
Sponsor
First posted
Apr 21, 2023
Start date
Apr 29, 2023 (estimated)
Primary completion
Aug 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Apr 21, 2023

Study contacts

yi feng
Contact
yifeng65@sina.com
010-88325988
yi feng
principal investigator · Peking University People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Amisulpride

Start the discussion