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

PONV Clinical Trial

Official title:

Randomized, Double-blind, Placebo-controlled Phase III Study of Amisulpride for IV Injection as Prophylaxis Against Post-operative Nausea and Vomiting

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05822713
• Other study ID #: QLG2069-AMS-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 29, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Qilu Pharmaceutical (Hainan) Co., Ltd.
• Contact: yi feng
• Phone: 010-88325988
• Email: yifeng65[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 516
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion 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.

Related Conditions & MeSH terms

• PONV

Intervention

Drug:
• Amisulpride
5mg/2ml
• Amisulpride Placebo
2ml

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical (Hainan) Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours after the end of surgery
Secondary	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	24 hours after end of surgery
Secondary	Incidence of moderate and severe Nausea	Count of participants with nausea score > 4 on 0-10 verbal response scale	24 hours after end of surgery
Secondary	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	24 hours after end of surgery
Secondary	Use of Rescue Medication		24 hours after end of surgery
Secondary	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	24 hours after end of surgery