Reduced-exposure neuromuscular blockade strategies for total laparoscopic hysterectomy within an ERAS pathway: a randomized controlled trial

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Abstract

BACKGROUND: Neuromuscular blocking agents (NMBAs) facilitate tracheal intubation and laparoscopic exposure, but residual neuromuscular blockade remains a perioperative concern. We evaluated whether reducing NMBA exposure during total laparoscopic hysterectomy within an Enhanced Recovery After Surgery (ERAS) pathway maintained airway and operative conditions while limiting interpretation of postoperative neuromuscular outcomes to the available measurements. METHODS: In this single-center, randomized, patient-, surgeon-, postoperative assessor-, and statistician-blinded, parallel-group trial, 135 patients scheduled for elective total laparoscopic hysterectomy were allocated 1:1:1 to no muscle relaxant (NM), rocuronium for induction only (MI), or rocuronium for induction plus maintenance (MIC). After post-randomization exclusions, 130 patients were included in the modified intention-to-treat cohort. The primary endpoint was the proportion of patients achieving clinically acceptable intubating conditions, defined as excellent or good Cooper grades; the full Cooper grade distribution was reported as a supportive outcome. Surgical workspace quality, Cormack-Lehane grades, extubation time, and recovery measures were secondary or supportive outcomes, whereas pain scores and inflammatory biomarkers were analyzed as exploratory outcomes. RESULTS: Successful tracheal intubation was achieved in all analyzed patients. Clinically acceptable intubating conditions were observed in 43/45 patients (95.6%; 95% CI, 84.9%-99.5%) in the NM group, 43/43 patients (100.0%; 95% CI, 91.8%-100.0%) in the MI group, and 42/42 patients (100.0%; 95% CI, 91.6%-100.0%) in the MIC group, with no statistically significant between-group differences observed. No statistically significant between-group differences were observed in Cormack-Lehane grades, surgical workspace scores, extubation time, PACU stay, or hospital stay. In exploratory analyses, VAS pain scores at 2 and 4 h and immediate postoperative IL-6 concentrations were higher in the MIC group than in the other groups; a between-group difference was also observed for immediate postoperative TNF-alpha, with the highest mean value in the MI group. No chest-wall rigidity, difficult mask ventilation, failed intubation, or rescue NMBA administration for intubation difficulty occurred, and recorded adverse events were mainly postoperative nausea and vomiting. CONCLUSION: In this study, reduced NMBA exposure was not associated with differences in clinically acceptable intubating conditions, surgical workspace quality, or early recovery outcomes among selected patients undergoing elective total laparoscopic hysterectomy within an ERAS pathway. These findings suggest that reducing NMBA exposure may be feasible under carefully standardized anesthetic conditions. Further prospective studies incorporating quantitative neuromuscular monitoring are warranted to validate these findings. TRIAL REGISTRATION: The study was registered at the Chinese Clinical Trial Registry ( http://www.chictr.org.cn ) with the number ChiCTR2400080065 on January 19, 2024, after project approval in July 2021, ethics approval before enrollment in September 2022, and completion of the study period.

Abstract as published, via PubMed.