Influence of Mild Hypothermia on Reversal of Rocuronium With Sugammadex

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MSD Korea Ltd.
• Treatments: Rocuronium

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