Clinical trial NCT06417567: The Safety and Effectiveness of NEPA in Preventing Postoperative Nausea and Vomiting After General Anesthesia Gastrointestinal Cancer Surgery: A Single-Center Retrospective Study
Official title: The Safety and Effectiveness of NEPA in Preventing Postoperative Nausea and Vomiting After General Anesthesia Gastrointestinal Cancer Surgery: A Single-Center Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: General Anesthesia Gastrointestinal Cancer Surgery
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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


Eligibility 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.

Primary outcomes:
measure: Complete response rate within 24 hours after surgery
timeFrame: 3month
Secondary outcomes:
measure: Complete response rates in the early postoperative period (0-2 hours), delayed period (2-24 hours), and extended observation period (24-48 hours)
timeFrame: Complete response rates in the early postoperative period (0-2 hours), delayed period (2-24 hours), and extended observation period (24-48 hours)
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
Study officials:
References: