Phase 4 Completed N=60 Randomized Quadruple-blind Treatment

Influence of Mild Hypothermia on Reversal of Rocuronium With Sugammadex

Underdosing of Other General Anesthetics

Source: ClinicalTrials.gov NCT01965067 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcomePrimary: Reversal Time of Rocuronium — 124.9; 171.1 seconds

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Reversal Time of Rocuronium	124.9; 171.1	—
SECONDARY Mean Arterial Blood Pressure	89.9; 91.6; 88.4; 89.6; 87.5; 90.2	—
SECONDARY Heart Rate	77.5; 77.8; 71.8; 72.9; 70.7; 73.1	—

Eligibility Criteria

Inclusion Criteria

Patient for elective abdominal surgery from 20 years (yrs) to 65 yrs Patient in American Society of Anesthesiologists criteria 1 or 2 Patient in the supine position with arm available for neuromuscular monitoring during operation

Exclusion Criteria

Patients expected to have a difficult airway, known neuromuscular disease, significant hepatic or renal dysfunction, family history of malignant hyperthermia, known allergy to one of the drugs used in this protocol, intake of any medication that might interact with muscle relaxants, pregnant, or breast feeding

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Data sourced from ClinicalTrials.gov (NCT01965067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.