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Recruiting
NCT05688384
Patient-Controlled Sedation in Port Implantation (PACSPI-2)
Conditions: Pain, Patient Satisfaction, Cancer, Venous Puncture
Sex: All
Ages: 18 Years – 110 Years
Phase: PHASE4
Enrollment: 340
Sponsor: Region Jönköping County
Location: Sweden
Summary
The goal of the study is to determine if patient-controlled sedation (PCS) with propofol and alfentanil reduces patient-reported pain perception during implantation of subcutaneous venous port (SVP).The main question it aims to answer: How much pain did you (patient) experience during SVP-implantation Several other questions will be answered regarding: patient´s perception of the procedure, complication rate, procedure data.The study contains two groups which will be compared.
Control group: will do SVP implantation under local anaesthesia Study group: will do SVP implantation under local anaesthesia and patient-controlled sedation.The patients are asked to complete a questionnaire postoperatively which contains questions on pain perception and satisfaction.
Eligibility Criteria
Inclusion Criteria:Patients ≥18 years with cancer in need of SVP.Exclusion Criteria:Inability to operate the PCS apparatus.Inability to communicate in Scandinavian languages.Patients who require general anaesthesia or patients eligible for LA only on anesthesiologist´s assessment (i.e.
severe sleep apnea).Propofol or alfentanil allergy.Non-fasting according to guidelines of the Swedish Society for Anaesthesia and Intensive Care (SFAI).Failure to achieve peripheral vascular access.PregnancyPrevious participation in study
Source: ClinicalTrials.gov (NCT05688384). StuddyBuddy aggregates publicly available trial information.