Safety of Sugammadex for the Reversal of Neuromuscular Blockade in American Society of Anesthesiologists (ASA) Class 3 or 4 Participants (MK-8616-145)

Summary

The purpose of this trial is to evaluate the safety of sugammadex for the reversal of neuromuscular blockade (NMB) induced by neuromuscular blockade agents (NMBA) rocuronium or vecuronium in adult American Society of Anesthesiologists (ASA) Physical Status Class 3 and 4 participants. The primary objectives of the study are to characterize the incidence of treatment emergent sinus bradycardia, treatment emergent sinus tachycardia, or other treatment emergent cardiac arrhythmias after administration of sugammadex and to evaluate the general safety of sugammadex in a population of ASA Class 3 and 4 participants in a surgical setting.

Timeline

Start

2017-12-20

Primary completion

2019-09-04

Completion

2019-09-04

Outcome

Mixed primary results

registry Sugammadex 2 mg/kg vs Neostigmine + Glycopyrrolate; p = 0.026; Estimated Difference in percentage -6.7 (95% CI -17.5 to -0.8) NCT03346057 ↗

registry Sugammadex 16 mg/kg vs Neostigmine + Glycopyrrolate; p = 0.730; Estimated Difference in percentage -2.0 (95% CI -17.8 to 8.6) NCT03346057 ↗

paper No significant differences in other TE cardiac arrythmias were seen between sugammadex groups and neostigmine/glycopyrrolate. PMID 34711192 ↗

Publications

• Herring WJ, Mukai Y, Wang A, Lutkiewicz J, Lombard JF, Lin L, Watkins M, Broussard DM, Blobner M. A randomized trial evaluating the safety profile of sugammadex in high surgical risk ASA physical class 3 or 4 participants. BMC Anesthesiol. 2021 Oct 28;21(1):259. doi: 10.1186/s12871-021-01477-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Glycopyrrolate	Small molecule	10 ug/kg	Intravenous
Comparator	Neostigmine	Other / unclassified	50 ug/kg	Intravenous
Subject	Sugammadex	Other / unclassified	2 mg/kg	Intravenous
Subject	Sugammadex	Other / unclassified	4 mg/kg	Intravenous
Subject	Sugammadex	Other / unclassified	16 mg/kg	Intravenous
Background	Rocuronium	Other / unclassified	—	Intravenous
Background	Vecuronium	Small molecule	—	Intravenous

Indications

No indication recorded.