Nausea and vomiting in the home (after discharge) after day-case surgery under general anesthesia- MedDRA version: 18.1 Level: HLT Classification code 10028817 Term: Nausea and vomiting symptoms System Organ Class: 100000004856 MedDRA version: 18.1 Level: LLT Classification code 10036285 Term: Postoperative nausea System Organ Class: 100000004863 MedDRA version: 18.1 Level: LLT Classification code 10036901 Term: Prophylaxis against postoperative nausea and vomiting System Organ Class: 1000000
Conditions
Interventions
Trade Name: ALOXI
Product Name: Aloxi
Pharmaceutical Form: Injection
INN or Proposed INN: PALONOSETRON
CAS Number: 135729-56-5
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equ
Sponsors
Umeå University
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate if palonosetron (com-pared to placebo) can reduce the incidence of postdischarge nausea and vomiting (PDNV) in patients with high risk for PDNV. In the high-risk group incidences of 40-50% are reported and a reduction in PDNV of 50% during the first 48 hours is clinically relevant. ;Secondary Objective: Secondary objectives: -Incidences of PDNV in the high risk group. Incidences of adverse reactions related to palonosetron (headache, constipation, dizzyness) - Incidence of PDNV in a low-risk group of patients (those who are not randomized). - Safety evaluations ;Primary end point(s): Complete response defined as no nausea or no vomiting or no rescue anti-emetics from discharge to the postop day 2.;Timepoint(s) of evaluation of this end point: With questionnaires once daily until the evening on the second day after the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): periods until postop day 3 - Need for rescue medications. - Adverse Events - Headache - Constipation - Visual disturbances - Re-admissions ;Timepoint(s) of evaluation of this end point: With questionnaires once daily until the evening on the third day after the procedure. A review of the patients chart at 28 days after the procedure. | — |
Countries
Sweden
Contacts
Public ContactJakob Wallden
Umeå University
Outcome results
None listed