CTRI/2024/04/065708尚未招募4 期
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. - NI
a Renon Healthcare Pvt. Ltd.,0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Male or female patients aged between 18 to 75 years (both inclusive).
- •2. 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.
- •3. Patients with the Body Mass Index (BMI) = 30 kg/m2 at screening visit.
- •4. 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.
- •5. Patients with American Society of Anesthesiologists (ASA) risk score I-III.
- •6. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening visit.
- •7. Patients with ability to fully understand the study procedures and provide written, signed and dated informed consent form.
- •8. Patients willing to comply with all the protocol related requirements.
排除标准
- •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 anesthetic 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 or female =460 ms).
- •7. 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.
- •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. Patients with a history of intestinal obstruction.
- •12. Patients with a known history of prolactin-dependent tumor (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 and Sparfloxacin.
- •16. Patients being treated with Levodopa or other dopamine drugs.
- •17. Female patients who are pregnant or breast feeding.
- •18. Patients with a history of drug or alcohol abuse within 6 months before enrollment.
- •19. Patients diagnosed with Parkinson disease.
- •20. Patients with a history of epilepsy.
- •21. Patients who have received anti-cancer chemotherapy in the previous 4 weeks of surgery.
- •22. Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- •23. Patients 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 enrolment by the investigator.
研究者
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