Can the drug palonosetron reduce the risk for postdischarge nausea and vomiting the days after ambulatory surgery?

Phase 1

• Conditions: MedDRA version: 18.1Level: LLTClassification code 10036285Term: Postoperative nauseaSystem Organ Class: 100000004863; ausea and vomiting in the home (after discharge) after day-case surgery under general anesthesia-; MedDRA version: 18.1Level: HLTClassification code 10028817Term: Nausea and vomiting symptomsSystem Organ Class: 100000004856; MedDRA version: 18.1Level: LLTClassification code 10036901Term: Prophylaxis against postoperative nausea and vomitingSystem Organ Class: 100000004865; MedDRA version: 18.1Level: LLTClassification code 10028818Term: Nausea postoperativeSystem Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]; MedDRA version: 18.1Level: LLTClassification code 10054182Term: Perioperative nausea and vomiting prophylaxisSystem Organ Class: 100000004865

• Registration Number: EUCTR2015-003956-32-SE
• Lead Sponsor: meå University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-14
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

1)Male or female, >=18 years of age, who has given written consent for his/her participation to the study
2)Women of Childbearing Capacity (WOCBC) only if pregnancy test is negative or if the woman is using effective contraception methods. Acceptable meth-ods are such as oral contraceptives, contraceptive patches, contraceptive implant, vaginal contracep-tive, double-barrier methods (for example, condom and spermicide), intrauterine device (IUD), hormo-nal IUD and abstinence.
3)Scheduled for surgery under general anesthesia and planned to be discharged from the hospital the same day as surgery.
4)Able to understand and cooperative with the study protocol.
5)ASA-class I-II

To enter the randomization arm:
6) POstoperative PDNV-score >=3

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

1)Documented allergy or intolerance to study drugs
2)Severe psychiatric condition or other reasons that jeopardize compliance with follow up.
3)On fertile females, pregnancy assessed by anamnesis and pregnancy test.
4)Breast-feeding females
5)Intestinal obstruction, accessed by anamnesis or clinical findings.
6)Concomitant treatment with SSRI or SNRI

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified