Patient-controlled sedation for implantation of subcutaneous venous ports- a randomized controlled trial

Phase 1

• Conditions: Patients =18 years with cancer in need of subcutaneous venous port will be offered to participate in the trial. The aim of the trial is to determine if patient-controlled sedation (PCS) with propofol and alfentanil reduces pain perception during implantation of subcutaneous venous port (SVP) in cancer patients.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2021-003821-31-SE
• Lead Sponsor: Region Jönköping, Sweden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-11
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

•Adult patients (=18 years) with cancer scheduled for SVP-implantation at participating anaesthesia departments.

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 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

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.
•Pregnancy
•Previous participation in study
All exclusion criteria as per implantation team´s assessment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified