Patient-Controlled Sedation in Port Implantation (PACSPI 1) – a Feasibility Trial

Abstract

Purpose: Central venous access is essential for the administration of chemotherapy and frequent blood sampling in patients with cancer. The subcutaneous venous port (SVP) is commonly used for this purpose. SVP implantation is a minor surgical procedure; however, it can provoke pain and anxiety in these vulnerable patients. The aim of this study was to determine the feasibility and safety of patient-controlled sedation (PCS) with propofol and alfentanil as an adjunct to local anesthesia during SVP implantation.Methods: We prospectively studied 40 patients scheduled for SVP implantation between April 14, 2021, and October 15, 2021, at a 500-bed secondary level hospital in Sweden. Anesthesiologists performed SVP implantation with PCS using propofol and alfentanil. We determined pain perception (primary outcome), patient satisfaction, sedation score, and key safety measures.Results: Of the 40 patients with cancer, 80% reported a pain score ≤3 on an 11-point numeric rating scale (NRS) during SVP implantation. Overall satisfaction with pain management and operating conditions was graded as 10 of 10 on the NRS. Four patients (10%) had bradypnea (<8 breaths/min) without oxygen desaturation to ≤90%. Rescue sedation was administered to one patient (2.5%). Conclusion: PCS with propofol and alfentanil during SVP implantation is feasible, safe, and well accepted. Its efficacy must be evaluated in a randomized controlled trial to provide clinicians with evidence-based guidance for choosing the optimal perioperative strategy for SVP implantation.Trial registration number at clinicaltrials.gov: NCT04631393 before study commencement.