Patient-Controlled Sedation in Port Implantation (PACSPI 1) - A feasibility trial.

Background: Central venous access is essential for the administration of chemotherapy and frequent blood sampling in patients with cancer. The subcutaneous venous port is commonly used for this purpose. Subcutaneous venous port implantation is a minor surgical procedure; however, it can provoke pain and anxiety in these vulnerable patients. The aim of this study was, before a full-scale RCT, to determine the feasibility of patient-controlled sedation with propofol and alfentanil as an adjunct to local anaesthesia during SVP implantation. Methods: We prospectively studied 40 patients scheduled for SVP implantation between 14 April 2021 and 15 October 2021 at a 500-bed secondary level hospital in Sweden. Anaesthesiologists performed subcutaneous venous port implantation with patient-controlled sedation 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 during subcutaneous venous port implantation. Overall satisfaction with pain management and operating conditions was graded as 10 of 10 on the numeric rating scale. Four patients (10%) had bradypnoea (<8 bpm) without oxygen desaturation to ≤90%. Rescue sedation was administered to one patient (2.5%). Conclusion: Patient-controlled sedation with propofol and alfentanil during subcutaneous venous port implantation is feasible and well accepted. Ultimately the efficacy of patient-controlled sedation with propofol and alfentanil needs to be evaluated in an RCT to provide clinicians with evidence-based guidance for choosing the optimal perioperative strategy for subcutaneous venous port implantation. Clinical trial registration: NCT04631393.