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

NCT05822713 | Unknown Phase 3

• 1 other identifier: QLG2069-AMS-301
• Study Type: interventional
• Target: 516
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

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

  24 hours after the end of surgery

Secondary Outcomes (5)

• Incidence of no Nausea

  24 hours after end of surgery

• Incidence of moderate and severe Nausea

  24 hours after end of surgery

• Incidence of Emesis (Vomiting/Retching)

  24 hours after end of surgery

• Use of Rescue Medication

  24 hours after end of surgery

• Time to First Violation of Criteria for PONV

  24 hours after end of surgery

Study Arms (2)

Experimental

EXPERIMENTAL

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

Drug: Amisulpride

Placebo

PLACEBO COMPARATOR

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

Drug: Amisulpride Placebo

Interventions

Amisulpride DRUG

5mg/2ml

Experimental

Amisulpride Placebo DRUG

2ml

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent.
• Male or female patients ≥ 18 years of age and ≤75 years of age.
• \<BMI≤30kg/m\^2，And weigh more than 45kg
• 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;
• 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
• American Society of Anesthesiologists (ASA) risk score I-III -

You may not qualify if:

• Patients undergoing day case surgery
• 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
• Patients planned to receive only a local anaesthetic and/or regional neuraxial (intrathecal or epidural) block
• Patients who are scheduled to be transferred to the ICU after surgery;
• Patients who are expected to need a naso- or oral-gastric tube in situ after surgery is completed
• Patients who have a documented, clinically significant cardiac arrhythmia or congenital long QT syndrome（Male≥ 450 ms female≥ 460ms）.
• 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
• Patients who have received Amisulpride active ingredient for any indication within the last 2 weeks
• Patients who are allergic to Amisulpride active ingredient or any of the excipients of Amisulpride
• Patients with a significant, ongoing history of vestibular disease or dizziness
• Intestinal obstruction
• Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or breast cancer) or phaeochromocytoma.
• Patients with pre-existing nausea or vomiting in the 24 hours before surgery
• Patients treated with regular anti-emetic therapy including corticosteroids
• 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

Sponsors & Collaborators

• Qilu Pharmaceutical (Hainan) Co., Ltd.: lead

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Amisulpride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• yi feng

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yi feng

CONTACT

010-88325988; yifeng65@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 21, 2023
• Study Start: April 29, 2023
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share