drugset / Trial / NCT01965067

Influence of Mild Hypothermia on Reversal of Rocuronium With Sugammadex

NCT01965067

Phase 4 Completed 60 enrolled MSD Korea Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary efficacy endpoint is the time from the start of administration of sugammadex to recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic count) induced by rocuronium during mild hypothermia with core temperatures between 34.5°C and 35°C, and compared with the normal thermal condition. Secondary endpoints include time from the start of administration of sugammadex to recovery of the TOF ratio to 0.7 or 0.8 in both groups, vital signs \[heart rate and blood pressure\] at pre-reversal, post-reversal, recovery and post-anesthetic visit, the incidence of residual neuromuscular blockade, post-operative nausea and vomiting (PONV) and adverse events during mild hypothermia and the normal thermal condition. We hypothesize that mild hypothermia with core temperatures between 34.5°C and 35°C diminish the efficacy of sugammadex.

Timeline

Start
2013-10
Primary completion
2014-02
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Sugammadex Other / unclassified 4 mg/kg Intravenous

Indications

No indication recorded.