A Phase IV, Prospective, Single Arm, Multi-Center, Open Label Clinical Study to Evaluate the Efficacy and Safety of Amisulpride 5 mg/2 mL for IV Injection in Prevention of Post-Operative Nausea and Vomiting (PONV) in Adult Surgical Patients.
概览
- 阶段
- Post Marketing Surveillance
- 状态
- 已完成
- 发起方
- La Renon Healthcare Pvt. Ltd.,
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- No episodes of emesis (vomiting or retching) and no use of rescue medication in the first 24h after surgery.
概览
简要总结
This is a phase IV, Prospective, Single Arm, Multi-Center, Open Label Clinical Study to Evaluate the Efficacy and Safety of Amisulpride 5 mg/2 mL for IV Injection in Prevention of Post-Operative Nausea and Vomiting (PONV) in Adult Surgical Patients.
Patients who are willing and able to participate in the study will sign and date the Informed Consent Form on the day of screening visit (Visit 1). During this screening period, patients who are willing to give consent will be evaluated for all the eligibility criteria. Eligible patients aged between 18 to 75 years (both inclusive) fulfilling all inclusion criteria and none of the exclusion criteria will be considered for the study.
After confirming all inclusion criteria and none of the exclusion criteria the patient will be enrolled into the study.
All eligible patients will be screened and enrolled in the study. Eligible patients will be enrolled to receive the treatment of Amisulpride 5 mg/2 mL IV as a single dose before surgery at the time of Anaesthesia administration.
研究设计
- 研究类型
- Pms
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients aged between 18 to 75 years (both inclusive).
- •Patients undergoing elective surgery (laparoscopic gynecological or abdominal surgery) under general anaesthesia requiring and inhalation anaesthesia 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: a.
- •Past history of PONV and/or motion sickness b.
- •Habitual non-smoking status c.
- •Female sex d.
- •Expected to receive opioid analgesia post-operatively.
- •Patients with American Society of Anesthesiologists (ASA) risk score I-III.
- •Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study.
- •Patients with ability to fully understand the study procedures and provide written, signed and dated informed consent form.
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 anesthetic 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 or female ≥460 ms).
- •Patients with clinically significant impaired hepatic and renal function (ALT and/or AST ≥2.5 X the ULN, Total bilirubin ≥1.5 X the ULN and/or Serum creatinine ≥1.5 X ULN) at screening visit.
- •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.
结局指标
主要结局
No episodes of emesis (vomiting or retching) and no use of rescue medication in the first 24h after surgery.
时间窗: Visit 2 - Baseline or Enrolment visit / Day 1 and | Visit 3 - End of the study visit / Day 2.
次要结局
- Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery.(Visit 2 - Baseline or Enrolment visit / Day 1 and)
- Number of patients experiencing an episode of no nausea scored Less than 1 of 0-10 verbal response scale during the 24 hours period after the completion of surgery.(Visit 2 - Baseline or Enrolment visit / Day 1 and)
- Number of patients with nausea score Greater than 4 on 0-10 verbal response scale.(Visit 2 - Baseline or Enrolment visit / Day 1,)
- An assessment of a patient experiencing an episode of emesis (vomiting/ retching) during the 24 hours after the completion of the surgery.(Visit 2 - Baseline or Enrolment visit / Day 1 and)
- Adverse events or serious adverse events reported during the study.(Throughout the Study)
研究者
Dr Rajasekhara Reddy Tamma
Clinwave Research Pvt. Ltd.