FOSAPREPITANT for Post-operative nausea and vomiting (PONV)

Inclusion criteria

• {"criterion_text":"- The subject has given their written consent to participate in the trial"}
• {"criterion_text":"- Adult male or female subjects (>=18 years old)"}
• {"criterion_text":"- ASA-class I-III"}
• {"criterion_text":"- Scheduled for elective laparoscopic bariatric surgery or laparoscopic cholecystectomies under general anesthesia"}
• {"criterion_text":"- Women of Childbearing Capacity (WOCBC) only if pregnancy test is negative or if the woman is using highly effective contraception methods"}

Exclusion criteria

• {"criterion_text":"- Not able to understand and/or cooperative with the study protocol."}
• {"criterion_text":"- Documented allergy or intolerance to the IMPs."}
• {"criterion_text":"- Psychiatric condition or other reasons that jeopardize compliance with follow up."}
• {"criterion_text":"- Breast-feeding females"}
• {"criterion_text":"- Intestinal obstruction, accessed by anamnesis or clinical findings."}
• {"criterion_text":"- Immunosuppressive treatment."}
• {"criterion_text":"- Medication with SSRI or SNRI."}
• {"criterion_text":"- Female subjects using anticontraceptive drugs not accepting the need for alternative contraceptive methods for two months (if anticonception is desired by the subject)."}

Primary endpoints

• {"endpoint_text":"- QoR-15swe scores preoperative (baseline) and on POD1","definition_or_measurement_approach":"Measured using the QoR-15swe instrument at baseline (preoperative) and on postoperative day 1 (POD1)."}

Secondary endpoints

• {"endpoint_text":"- QoR-15swe on POD0, POD2 and POD3","definition_or_measurement_approach":"Measured using the QoR-15swe instrument on POD0, POD2 and POD3."}
• {"endpoint_text":"- Events of nausea or vomiting at PACU, at the hospital and at home up to POD3.","definition_or_measurement_approach":"Recording of nausea and vomiting events at PACU, during hospital stay and at home up to postoperative day 3."}
• {"endpoint_text":"- Use of antiemetics at PACU, at the hospital and at home up to POD3.","definition_or_measurement_approach":"Recording of antiemetic use at PACU, during hospital stay and at home up to POD3."}
• {"endpoint_text":"- Pain assessments (NRS) at PACU, during hospital stay and at home up to POD3.","definition_or_measurement_approach":"Pain measured by Numerical Rating Scale (NRS) at PACU, during hospital stay and at home up to POD3."}
• {"endpoint_text":"- Time at PACU","definition_or_measurement_approach":"Duration of stay in the Post Anesthesia Care Unit (PACU)."}
• {"endpoint_text":"- Time at hospital until discharge.","definition_or_measurement_approach":"Time from surgery to hospital discharge."}
• {"endpoint_text":"- Events of known side-effect of IMP such as infusion-site reactions, headache, visual disturbances, constipation, diarrhoea and tiredness.","definition_or_measurement_approach":"Recording of specified adverse events and side effects during the observation period."}
• {"endpoint_text":"- Complications from POD0 to POD 30 according to Clavien-Dindo","definition_or_measurement_approach":"Complications graded according to the Clavien-Dindo classification from POD0 to POD30."}
• {"endpoint_text":"- Themes from qualitative interviews of patient experiences on postoperative recovery using inductive thematic analysis (30-90 days after first visit)","definition_or_measurement_approach":"Qualitative interviews conducted 30-90 days after first visit; themes identified using inductive thematic analysis."}

Sweden

Earliest CTIS Part Ii Submission Date

03-12-2025

Latest Decision Or Authorization Date

15-12-2025

Processing Time Days

12

Number Of Sites

3

Number Of Participants

220

Primary sponsor

Full Name

Region Vaesternorrland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Co-sponsors

• Umea University