AIM: To assess the impact of spinal anesthesia (SpA) combined with three different forms of conscious sedation on intraoperative and postoperative outcome in patients undergoing radical retropubic prostatectomy (RRP) for organ confined prostate cancer (pCa). METHODS: A total of 121 consecutive patients with pCa undergoing RRP were randomized into four groups. They were randomized as follows: group 1 (general anesthesia: 34 patients), group 2 (lumbar 2 to lumbar 3 interspace SpA with diazepam as sedative agent: 28), group 3 (SpA with propofol: 30), and group 4 (SpA with midazolam: 29). Intraoperative and perioperative parameters were collected. RESULTS: The present study showed that muscle relaxation throughout RRP was not different in the four groups; bleeding was significantly (P = 0.04) lower with SpA, regardless of the form of sedation. Group 3 patients reported the best postoperative oxygen saturation percentage by pulse oximetry and sedation score (P = 0.02; d.f. = 3 and P < 0.0001; d.f. = 3, respectively), the shortest waiting time in the postoperative holding area (P < 0.001; d.f. = 3), the lowest pain on postoperative day 1 (P = 0.0004; d.f. = 3), and the highest frequency of first flatus passage (P = 0.0001; d.f. = 3). A higher number of group 4 patients were able to carry out unassisted ambulation (P < 0.0001; d.f. = 3). CONCLUSIONS:Conscious sedation coupled with SpA is a safe, reliable and effective procedure for patients undergoing RRP. The use of propofol as sedative agent offers several advantages both over other types of conscious sedation and general anesthesia.
RCT Entities:
AIM: To assess the impact of spinal anesthesia (SpA) combined with three different forms of conscious sedation on intraoperative and postoperative outcome in patients undergoing radical retropubic prostatectomy (RRP) for organ confined prostate cancer (pCa). METHODS: A total of 121 consecutive patients with pCa undergoing RRP were randomized into four groups. They were randomized as follows: group 1 (general anesthesia: 34 patients), group 2 (lumbar 2 to lumbar 3 interspace SpA with diazepam as sedative agent: 28), group 3 (SpA with propofol: 30), and group 4 (SpA with midazolam: 29). Intraoperative and perioperative parameters were collected. RESULTS: The present study showed that muscle relaxation throughout RRP was not different in the four groups; bleeding was significantly (P = 0.04) lower with SpA, regardless of the form of sedation. Group 3 patients reported the best postoperative oxygen saturation percentage by pulse oximetry and sedation score (P = 0.02; d.f. = 3 and P < 0.0001; d.f. = 3, respectively), the shortest waiting time in the postoperative holding area (P < 0.001; d.f. = 3), the lowest pain on postoperative day 1 (P = 0.0004; d.f. = 3), and the highest frequency of first flatus passage (P = 0.0001; d.f. = 3). A higher number of group 4 patients were able to carry out unassisted ambulation (P < 0.0001; d.f. = 3). CONCLUSIONS: Conscious sedation coupled with SpA is a safe, reliable and effective procedure for patients undergoing RRP. The use of propofol as sedative agent offers several advantages both over other types of conscious sedation and general anesthesia.