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

Last updated: May 12, 2024
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vomiting

Digestive System Neoplasms

Gastric Ulcers

Treatment

NEPA

Clinical Study ID

NCT06417567
NEPA
  • Ages 18-65
  • All Genders

Study 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

Inclusion Criteria:

  1. Male or female, aged 18-65 years old; 2. The subjects were diagnosed withliver, gallbladder, and pancreatic diseases through histology or cytology andunderwent elective surgical treatment, including but not limited topancreaticoduodenectomy, liver resection, bile duct stone removal, etc., andreceived treatment with Netopitam Palonosetron capsules; 3. The subject is notin lactation period; 4. When screening female patients with potentialpregnancy, it is necessary to confirm that the pregnancy test must be negative;
  2. The subjects voluntarily and strictly comply with the research protocolrequirements and sign a written informed consent form.

Exclusion

Exclusion Criteria:

  1. Serious liver and kidney dysfunction, cardiopulmonary dysfunction, or otherserious diseases have not received standardized treatment; 2) Having a seriousmental illness in the past; 3) Take antiemetics or antidepressants within 48hours before surgery; 4) Patients receiving systemic glucocorticoid treatmentwithin 4 weeks prior to surgery; 5) Take NK1 receptor antagonists or anyinvestigational drugs within 4 weeks prior to the start of the experiment; 6)Use CYP3A4 inducer within 4 weeks prior to surgery, and CYP3A4 substrate orpotent, moderate CYP3A4 inhibitor within 1 week; 7) Pregnant or lactatingwomen, patients with fertility who are unwilling or unable to take effectivecontraceptive measures; 8) Drug and/or alcohol abuse; 9) Hypocalcemia or anyother condition that may cause vomiting; 10) The subject has an allergicreaction 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 observationalresearch; 12) Researchers assess other situations that may affect the progressof clinical research and the determination of research results.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: NEPA
Phase:
Study Start date:
May 15, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

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