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Influence of Mild Hypothermia on Reversal of Rocuronium With Sugammadex

NCT01965067 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-08-15

Study results available
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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.

Conditions

  • Underdosing of Other General Anesthetics

Interventions

DRUG

sugammadex

sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state Reversal effect of sugammadex in temperature state

Sponsors & Collaborators

  • MSD Korea Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyo Sang Kim, MD, PhD · Department of Anesthesiology and Pain Medicine, Hanyang University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-02-28
Completion
2014-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01965067 on ClinicalTrials.gov