Influence of Mild Hypothermia on Reversal of Rocuronium With Sugammadex
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
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.