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Postoperative recovery with the addition of long-acting NK1- and 5-HT3 receptor antagonists as prophylaxis for post-operative nausea and vomiting. A prospective, double-blind, randomized trial in laparoscopic surgery.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522529-36-00
Acronym
Palpitant-study
Enrollment
220
Registered
2025-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative nausea and vomiting (PONV)

Brief summary

QoR-15swe scores preoperative (baseline) and on POD1

Detailed description

QoR-15swe on POD0, POD2 and POD3, Events of nausea or vomiting at PACU, at the hospital and at home up to POD3., Use of antiemetics at PACU, at the hospital and at home up to POD3., Pain assessments (NRS) at PACU, during hospital stay and at home up to POD3., Time at PACU, Time at hospital until discharge., Events of known side-effect of IMP such as infusion-site reactions, headache, visual disturbances, constipation, diarrhoea and tiredness., Complications from POD0 to POD 30 according to Clavien-Dindo, Themes from qualitative interviews of patient experiences on postoperative recovery using inductive thematic analysis (30-90 days after first visit)

Interventions

DRUGPALONOSETRON
DRUGSODIUM CHLORIDE
DRUGONDANSETRON

Sponsors

Region Vaesternorrland, Umea University
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
QoR-15swe scores preoperative (baseline) and on POD1

Secondary

MeasureTime frame
QoR-15swe on POD0, POD2 and POD3, Events of nausea or vomiting at PACU, at the hospital and at home up to POD3., Use of antiemetics at PACU, at the hospital and at home up to POD3., Pain assessments (NRS) at PACU, during hospital stay and at home up to POD3., Time at PACU, Time at hospital until discharge., Events of known side-effect of IMP such as infusion-site reactions, headache, visual disturbances, constipation, diarrhoea and tiredness., Complications from POD0 to POD 30 according to Clavien-Dindo, Themes from qualitative interviews of patient experiences on postoperative recovery using inductive thematic analysis (30-90 days after first visit)

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026