Phase 4
N=60
Influence of Mild Hypothermia on Reversal of Rocuronium With Sugammadex
Underdosing of Other General Anesthetics
Bottom Line
View on ClinicalTrials.gov: NCT01965067 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Reversal Time of Rocuronium — 124.9; 171.1 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- sugammadex (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- MSD Korea Ltd.
- Primary completion
- Feb 2014
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 | — |
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.
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
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.