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Effect of Neuromuscular Blockade and Reversal on Breathing

NCT02845375 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-02-19

Study results available
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Summary

In this study the investigators will assess (i) the effect of partial neuromuscular blockade (NMB; TOF ratio 0.8 and 0.6) induced by low-dose rocuronium on the ventilatory response to isocapnic hypoxia and (ii) the effect over time (from TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy volunteers.

Additionally the investigators will assess the effect of partial NMB (TOF ratio 0.6) induced by low-dose rocuronium on the ventilatory response to hypercapnia and effect over time (from TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy volunteers.

Conditions

  • Respiratory Insufficiency

Interventions

DRUG

Sugammadex

Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.

DRUG

Neostigmine

Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.

DRUG

Placebo

Placebo will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2018-09-01
Completion
2018-09-01

Countries

  • Netherlands

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 NCT02845375 on ClinicalTrials.gov