The Safety and Effectiveness of NEPA in Preventing Postoperative Nausea and Vomiting After General Anesthesia Gastrointestinal Cancer Surgery: A Single-Center Retrospective Study

The rapid progress of multiple antiemetic regimens ensures that patients can receive full dose chemotherapy, however, there are still a large number of unmet clinical needs in patient evaluation and treatment. Due to the fact that patients with liver, gallbladder, and pancreatic diseases undergoing surgery are still in the stage of nausea and vomiting, the actual incidence of delayed nausea and vomiting may be underestimated. The long-term effective control of nausea and vomiting by Nitopitan Palonosetron capsules may improve the quality of life of patients during and after treatment, and ultimately improve clinical outcomes

Study Overview

• Status: Recruiting
• Conditions: General Anesthesia Gastrointestinal Cancer Surgery
• Intervention / Treatment: Drug: NEPA

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute & Hospital
      • Contact: Huikai Li; Phone Number: 3091 +862223340123; Email: lihuikai@tjmuch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

This study is a retrospective study to evaluate the efficacy and safety of Netopitam Palonosetron Capsules in preventing nausea and vomiting caused by surgical treatment in patients with liver, gallbladder, and pancreatic diseases, providing evidence-based evidence and medication basis for the use of Netopitam Palonosetron Capsules in clinical practice.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
experimental group	Drug: NEPA; NEPA in Preventing Postoperative Nausea and Vomiting after General Anesthesia Gastrointestinal Cancer Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response rate within 24 hours after surgery	defined as no vomiting, no use of rescue medication, VAS nausea score<4	3month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response rates in the early postoperative period (0-2 hours), delayed period (2-24 hours), and extended observation period (24-48 hours)	Complete response rates in the early postoperative period (0-2 hours), delayed period (2-24 hours), and extended observation period (24-48 hours)	Complete response rates in the early postoperative period (0-2 hours), delayed period (2-24 hours), and extended observation period (24-48 hours)

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 12, 2024
• First Submitted That Met QC Criteria: May 12, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Signs and Symptoms, Digestive; Digestive System Neoplasms; Gastrointestinal Diseases; Nausea; Vomiting; Gastrointestinal Neoplasms; Postoperative Nausea and Vomiting
• Other Study ID Numbers: NEPA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No