Effects of postoperative palonosetron in ambulatory patients identified with high risk for postdischarge nausea and vomiting (PDNV) – a randomized controlled trial with comparison to placebo. - Palonosetron and PDNV

meå University0 个研究点目标入组 700 人开始时间: 2016年1月14日最近更新: 2020年7月6日

适应症

试验速览

暂无简介。

•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

•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

发起方

meå University