NCT05822713尚未招募3 期
Randomized, Double-blind, Placebo-controlled Phase III Study of Amisulpride for IV Injection as Prophylaxis Against Post-operative Nausea and Vomiting
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 516
- 主要终点
- The primary endpoint was the composite measure complete response
研究概览
简要总结
A comparison of the efficacy of Amisulpride and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
排除标准
- •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
- •Patients being treated with levodopa or other dopamine drugs
- •Patients who are pregnant or breast feeding.
- •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.
- •Patients who have received anti-cancer chemotherapy in the previous 4 weeks of surgery
- •Patients who have participated in other clinical research trials within 3 months before randomization
- •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.
研究组 & 干预措施
Experimental
Experimental
Amisulpride at 5mg was given by slow iv administration during1 to 2 min at induction of anesthesia
干预措施: Amisulpride (Drug)
Placebo
Placebo Comparator
Placebo was given by slow iv administration during1 to 2 min at induction of anesthesia
干预措施: Amisulpride Placebo (Drug)
结局指标
主要结局
The primary endpoint was the composite measure complete response
时间窗: 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
次要结局
- Incidence of no Nausea(24 hours after end of surgery)
- Incidence of moderate and severe Nausea(24 hours after end of surgery)
- Time to First Violation of Criteria for PONV(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)
研究者
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