NCT06417567RecruitingNot Applicable
The Safety and Effectiveness of NEPA in Preventing Postoperative Nausea and Vomiting After General Anesthesia Gastrointestinal Cancer Surgery: A Single-Center Retrospective Study
Tianjin Medical University Cancer Institute and Hospital1 site in 1 country50 target enrollmentStarted: May 15, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Complete response rate within 24 hours after surgery
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female, aged 18-65 years old;
- •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;
- •The subject is not in lactation period;
- •When screening female patients with potential pregnancy, it is necessary to confirm that the pregnancy test must be negative;
- •The subjects voluntarily and strictly comply with the research protocol requirements and sign a written informed consent form.
Exclusion Criteria
- •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.
Arms & Interventions
experimental group
Intervention: NEPA (Drug)
Outcomes
Primary Outcomes
Complete response rate within 24 hours after surgery
Time Frame: 3month
defined as no vomiting, no use of rescue medication, VAS nausea score\<4
Secondary Outcomes
- 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))
Investigators
Study Sites (1)
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