Comparison of Intravenous Sedation with Dexmedetomidine and Propofol for Breast Cancer Skin Lesion Electrochemotherapy: A Randomized, Double‐blinded Clinical Trial

Background: Skin metastases occur in 5% - 30% of breast cancer patients, highlighting the need for effective treatments. Electrochemotherapy, which combines electric pulses with chemotherapy, enhances drug uptake but requires sedation due to muscle spasms caused by the pulses. Dexmedetomidine, which minimizes respiratory depression, and propofol, which provides rapid sedation, are commonly used. However, research on their use specifically during electrochemotherapy is limited. Objectives: The aim of this study was to compare the efficacy of dexmedetomidine and propofol in breast cancer skin lesion electrochemotherapy. Methods: Sixty-four patients between the ages of 18 and 60 years, in ASA group II, I, III, with skin metastases of breast cancer were selected and referred for electrochemotherapy. The participants were randomly assigned to two equal groups, using sequentially numbered, opaque-sealed envelopes with computer-generated randomization. One group received dexmedetomidine, and the other received propofol. To minimize selection bias, an opaque covering was used to conceal the IV bag and tubing. Dexmedetomidine was administered to 32 patients with an initial bolus dose of 0.5 to 1 mcg/kg, followed by a continuous infusion of 0.1 to 1 mcg/kg per hour. Propofol was administered to the other 32 patients at a dose of 25 to 75 mcg/min/kg. Peripheral oxygen saturation (SpO2), mean arterial pressure (MAP), heart rate (HR), Ramsay Sedation Scale (RSS) score, Neuropathic Pain Scale (NPS) score, and Aldrete score were recorded during the procedure. The sample size was calculated for 80% power at a type I error of 0.05. Repeated-measures analysis of variance and independent-samples t-test were used to compare continuous variables. Results: The MAP decreased in the propofol group from time points 1 to 3 (P < 0.05) and in the dexmedetomidine group from time points 1 to 6 (P < 0.05), with significant differences between the groups at time points 1 to 3 (P < 0.05). Heart rate decreased in the dexmedetomidine group from time points 1 to 7 (P < 0.05), while the propofol group showed a decrease only at time point 2 (P < 0.05), with significant differences between the groups from time points 2 to 7 (P < 0.05). The SpO2 reduction was not significant in the dexmedetomidine group, while the propofol group exhibited a decrease from time points 1 to 3 (P < 0.05), with significant differences between the groups at time points 3 to 7 (P < 0.05). All patients in the dexmedetomidine group scored above 8 on the Aldrete scale, compared to 34.3% in the propofol group (P < 0.001). The mean RSS score during the procedure was significantly lower for the dexmedetomidine group than for the propofol group (P < 0.001). Overall patient satisfaction was similar between groups, but surgeon satisfaction was higher in the dexmedetomidine group (P < 0.001). No harm or unintended effects occurred in any of the patients. The generalizability of the findings may be limited due to variability in drug administration rates and timing across groups, as well as the exclusion of patients with cardiovascular disease and critically ill individuals. Conclusions: Dexmedetomidine provides satisfactory sedation and analgesia outcomes, making it a viable alternative to propofol for patients undergoing electrochemotherapy.