A clinical study to evaluate the efficacy and safety of Amisulpride injection for Prevention of Post-Operative Nausea and Vomiting (PONV) in Adult Surgical Patients.
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2024/04/065708
- Lead Sponsor
- a Renon Healthcare Pvt. Ltd.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o episodes of emesis (vomiting or retching) and no use of rescue medication in the first 24h after surgery.Timepoint: Visit 2 - Baseline or Enrolment visit / Day 1 and <br/ ><br>Visit 3 - End of the study visit / Day 2. <br/ ><br>
- Secondary Outcome Measures
Name Time Method