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Recovery of Diaphragmatic Function After Neuromuscular Blockade and Sugammadex

NCT01962298 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2018-10-24

Study results available
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Summary

The effect of neuromuscular blocking agents (NMBA, e.g. rocuronium) on respiratory muscle activity is well known. However, since the availability of sugammadex, to our knowledge, no study has been conducted to evaluate the effect of this novel product on these muscles.

Our hypothesis is that by applying a different strategy in the use of neuromuscular blocking agents and their reversal agents we might see a different activity of the respiratory muscles.

Conditions

  • Diaphragmatic Dysfunction
  • Muscle Weakness
  • Muscle Fatigue

Interventions

DRUG

sugammadex 2mg/kg

DRUG

neostigmine

DRUG

sugammadex 4mg/kg

DRUG

placebo

DRUG

Single rocuronium dose

DRUG

Repeated rocuronium dose

DRUG

Continuous rocuronium infusion

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Belgium

Study Locations

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Entities

Drugs

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 NCT01962298 on ClinicalTrials.gov