Using NEPA to prevent nausea and vomiting after gastrointestinal cancer surgery
The Safety and Effectiveness of NEPA in Preventing Postoperative Nausea and Vomiting After General Anesthesia Gastrointestinal Cancer Surgery: A Single-Center Retrospective Study
This study is testing if a new medication can help prevent nausea and vomiting after surgery for patients with gastrointestinal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06417567 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and effectiveness of Nitopitan Palonosetron (NEPA) in preventing postoperative nausea and vomiting in patients undergoing general anesthesia for gastrointestinal cancer surgeries. It focuses on patients diagnosed with liver, gallbladder, and pancreatic diseases who have undergone elective surgical treatments. The study aims to assess the long-term control of nausea and vomiting to improve patients' quality of life and clinical outcomes following surgery.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18-65 diagnosed with liver, gallbladder, or pancreatic diseases who are undergoing elective surgical treatment.
Not a fit: Patients with serious liver and kidney dysfunction, cardiopulmonary issues, or those who have taken antiemetics or antidepressants within 48 hours before surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life for patients recovering from gastrointestinal cancer surgery by effectively managing postoperative nausea and vomiting.
How similar studies have performed: While there is ongoing research in antiemetic regimens, this specific approach using NEPA in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Male or female, aged 18-65 years old; 2. The subjects were diagnosed with liver, gallbladder, and pancreatic diseases through histology or cytology and underwent elective surgical treatment, including but not limited to pancreaticoduodenectomy, liver resection, bile duct stone removal, etc., and received treatment with Netopitam Palonosetron capsules; 3. The subject is not in lactation period; 4. When screening female patients with potential pregnancy, it is necessary to confirm that the pregnancy test must be negative; 5. The subjects voluntarily and strictly comply with the research protocol requirements and sign a written informed consent form. Exclusion Criteria: * 1\) Serious liver and kidney dysfunction, cardiopulmonary dysfunction, or other serious diseases have not received standardized treatment; 2) Having a serious mental illness in the past; 3) Take antiemetics or antidepressants within 48 hours before surgery; 4) Patients receiving systemic glucocorticoid treatment within 4 weeks prior to surgery; 5) Take NK1 receptor antagonists or any investigational drugs within 4 weeks prior to the start of the experiment; 6) Use CYP3A4 inducer within 4 weeks prior to surgery, and CYP3A4 substrate or potent, moderate CYP3A4 inhibitor within 1 week; 7) Pregnant or lactating women, patients with fertility who are unwilling or unable to take effective contraceptive measures; 8) Drug and/or alcohol abuse; 9) Hypocalcemia or any other condition that may cause vomiting; 10) The subject has an allergic reaction to Netopitam Palonosetron capsules or any of their excipients; 11) Participate in another clinical study within 30 days prior to baseline visit, using any exploratory drugs or devices; Allow participation in observational research; 12) Researchers assess other situations that may affect the progress of clinical research and the determination of research results.
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.