Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery

Summary

This is a two period cross-over study randomizing patients undergoing laparoscopic surgery into 2 different groups: group 1 in which patients receive "deep neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "moderate blockade" and, group 2 in which patients receive "moderate neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "deep blockade". The deep neuromuscular block is defined as post tetanic count of 1 to 2 and the moderate neuromuscular block is defined as 1-2 twitches. In all patients, sugammadex is used to reverse the block at the end of surgery in order to obtain optimal extubating conditions.

Timeline

Start

2016-12-27

Primary completion

2019-01-17

Completion

2019-02-06

Outcome

Met primary endpoint

registry MEDIAN Deep NMB: Mean: 25.5 (23.6 to 30.3) cm H2O MEDIAN Moderate NMB: Mean: 28.3 (23.9 to 35.0) cm H2O NCT02812186 ↗

registry analysis (superiority test); Deep NMB vs Moderate NMB; p = 0.01; Wilcoxon (Mann-Whitney) NCT02812186 ↗

Drugs

Indications