Effects of depth of neuromuscular block on surgical operating conditions in women undergoing gynecologic laparoscopic surgery: a randomized clinical trial

Abstract

Background In recent years, the relationship between the advantages and disadvantages of a deep neuromuscular block (DNMB), compared to a moderate block (MNMB) in laparoscopic surgery, has been increasingly studied. Objective Evaluate the effect of D-NMB compared to M-NMB in gynecological laparoscopic surgery. Methods This was a parallel-group, double-blind, randomized clinical trial, conducted at a single center in Italy between February 2020 and July 2020. American Society of Anesthesiologist (ASA) I–II risk class patients scheduled for elective gynecological laparoscopic surgery were randomized into a 1:1 ratio to either experimental or control group. The first one included DNMB with a rocuronium bolus at the starting dose of 1.2 mg/kg and a maintenance dose (0.3–0.6 mg/kg/h). The second one included MNMB with a rocuronium bolus at the starting dose of 0.6 mg/kg, and a maintenance dose in boluses (0.15–0.25 mg/kg). The primary outcome was the intraoperative surgical condition assessed every 15 min by the surgeon as a 5-point scale. The secondary outcome was the time needed to discharge patients from post-anesthesia care unit (PACU). The tertiary outcome was the assessment of the intra-operative hemodynamic instability. A sample size of 50 patients was planned. Results One hundred five patients were assessed for eligibility, 55 were excluded. Fifty patients met the inclusion criteria and were enrolled. The average score for the operative field was 4 for the D-NMB group and 3 for the M-NMB group (p value < 0.01). The length of stay in PACU was 13 min for the DNMB group and 22 min for the MNMB group (p value = 0.02). Conclusions Deep neuromuscular block improves intraoperative surgical condition during gynecological laparoscopic surgery. Trial registration clinicalTrials.gov NCT03441828