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

NCT ID: NCT05822713

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 516 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-29
• Study Completion Date: 2023-12-31

Brief Summary

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

Conditions

PONV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

Amisulpride

Intervention Type: DRUG

5mg/2ml

Placebo

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

Group Type: PLACEBO_COMPARATOR

Amisulpride Placebo

Intervention Type: DRUG

2ml

Interventions

Amisulpride

5mg/2ml

Intervention Type: DRUG

Amisulpride Placebo

2ml

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participant understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent.

2. Male or female patients ≥ 18 years of age and ≤75 years of age.

3. 18<BMI≤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. American Society of Anesthesiologists (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, clinically significant cardiac arrhythmia or congenital long QT syndrome（Male≥ 450 ms female≥ 460ms）.

7. Adequate hepatic and renal function, Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2.5 x upper limit normal (ULN)，Bilirubin ≥ 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 excipients 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 corticosteroids

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical (Hainan) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

yi feng

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Central Contacts

yi feng

Role: CONTACT

yifeng65@sina.com

010-88325988

Other Identifiers

QLG2069-AMS-301

Identifier Type: -

Identifier Source: org_study_id