drugset / Trial / NCT01479764

Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)

NCT01479764 ↗

Phase 3 Completed 154 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will compare the incidence of residual neuromuscular blockade in participants who undergo reversal of neuromuscular blockade with sugammadex compared to those who undergo reversal of neuromuscular blockade with usual care (neostigmine/glycopyrrolate).

Timeline

Start
2011-12-02
Primary completion
2012-10-26
Completion
2012-11-05

Outcome

Met primary endpoint

paper Zero out of 74 sugammadex patients and 33 out of 76 (43.4%) usual care patients had TOF-Watch SX-assessed residual neuromuscular blockade at PACU admission PMID 25935840 ↗

paper (odds ratio 0.0, 95% CI [0-0.06], P<0.0001). PMID 25935840 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glycopyrrolate Small molecule — —
Comparator Neostigmine Other / unclassified — —
Subject Sugammadex Other / unclassified 2 mg/kg Intravenous
Subject Sugammadex Other / unclassified 4 mg/kg Intravenous

Indications

No indication recorded.