A Comparison of the Efficacy of Amisulpride and Placebo in the Prevention of PONV in Patients at Moderate-to-high Risk of PONV.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Amisulpride at 5mg was given by slow iv administration during1 to 2 min at induction of anesthesia |
Drug: Amisulpride
5mg/2ml
|
| Placebo Comparator: Placebo Placebo was given by slow iv administration during1 to 2 min at induction of anesthesia |
Drug: Amisulpride Placebo
2ml
|
Outcome Measures
Primary Outcome Measures
- The primary endpoint was the composite measure complete response [24 hours after the end of surgery]
defined as no episodes of emesis (vomiting or retching) and no use of rescue medication in the first 24h after wound closure
Secondary Outcome Measures
- Incidence of no Nausea [24 hours after end of surgery]
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
- Incidence of moderate and severe Nausea [24 hours after end of surgery]
Count of participants with nausea score > 4 on 0-10 verbal response scale
- Incidence of Emesis (Vomiting/Retching) [24 hours after end of surgery]
An assessment of a participant experiencing an episode of emesis (vomiting/ retching) during the 24hours after the completion of the 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]
Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
Inclusion Criteria:
-
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.
-
18<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 -
Exclusion Criteria:
-
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
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Patients who are scheduled to be transferred to the ICU after surgery;
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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
-
Patients being treated with levodopa or other dopamine drugs
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Patients who are pregnant or breast feeding.
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Participant who has a history of drug or alcohol abuse within 6 months before randomization
-
Patients diagnosed with Parkinson's disease ，Patients with a history of epilepsy.
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Patients who have received anti-cancer chemotherapy in the previous 4 weeks of surgery
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Patients who have participated in other clinical research trials within 3 months before randomization
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Qilu Pharmaceutical (Hainan) Co., Ltd.
Investigators
- Principal Investigator: yi feng, Peking University People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QLG2069-AMS-301