Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients

Inclusion Criteria:

1. Male or female patients aged from full-term birth to 17 years of age

2. Signed informed consent form and/or assent and willingness of patient and parents toparticipate in the trial

3. Patients undergoing non-emergency surgery, preferentially eye surgery,adenotonsillectomy or otoplasty, under general anesthesia (other than totalintravenous anesthesia with propofol) expected to last at least 30 minutes frominduction of anesthesia to removal of Endotracheal tube (ETT) or Laryngeal maskairway (LMA)

4. American Society of Anesthesiologists (ASA) risk score I-III

5. For females of child-bearing potential: ability and willingness to use a highlyeffective form of contraception (as defined in ICH M3 guidance, e.g., true (notperiodic) abstinence from sexual intercourse, surgical sterilization (of subject orpartner), combined oral contraceptive pill, or any other method or combination ofmethods with a failure rate generally considered to be <1% per year) between thedate of screening and at least 48 hours after administration of study drug.

Exclusion Criteria:

1. Patients scheduled to undergo transplant or Central Nervous System (CNS) surgery

2. Patients scheduled to receive only a local anesthetic and/or regional neuraxial (intrathecal or epidural) block (without general anesthesia) or to receive generalanesthesia involving total intravenous anesthesia (TIVA) with propofol

3. Patients who, in the opinion of the Investigator, are expected to remain ventilatedfor a significant period after surgery

4. Patients who are expected to need a naso- or orogastric tube in situ after surgeryis completed

5. Patients who are expected to receive systemic pre/peri-operative corticosteroidtherapy other than as anti-emetic prophylaxis

6. Patients receiving amisulpride for any indication within the 2 weeks prior torandomization

7. Patients known to be allergic to amisulpride or any of the excipients of amisulpridedrug product; or to dexamethasone or ondansetron

8. Patients with a significant ongoing history of vestibular disease or dizziness

9. Patients being treated with regular anti-emetic therapy (dosed at least three timesper week), which is still ongoing less than 1 week prior to screening

10. Patients being treated with levodopa, or any other dopamine D2-agonist

11. Patients who are pregnant or breast feeding

12. Patients with congenital long QT interval (QT) syndrome

13. Patients with a tumor of the anterior pituitary

14. Patients who have received emetogenic anti-cancer chemotherapy in the previous 4weeks

15. Any other concurrent disease or illness that, in the opinion of the investigatormakes the patient unsuitable for the study

16. Patients who have previously participated in this study or who have participated inanother interventional clinical study involving pharmacological therapy within theprevious 28 days (or longer exclusion period, if required by national or localregulations)

17. Where local laws/regulations require: patients under legal protection