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CompletedNCT03291184Updated Apr 10, 2018

Postoperative Residual Paralysis After Cardiac Surgery

An interventional study of peripheral neuromuscular monitor in Postoperative Residual Curarization, sponsored by Onze Lieve Vrouw Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-04-10.

Sponsored by Onze Lieve Vrouw Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The main objective of this study is to describe the incidence of postoperative residual paralysis (mean train-of-four \<90%) when weaning from the ventilator in patients admitted to the Intensive Care Unit (ICU) after elective cardiac surgery. Train-of-four monitoring is a widely used term for the peripheral nerve stimulation used in neuromuscular blockade monitoring. When the patient is ready for weaning from the ventilator, an ICU doctor will perform a measurement of the train-of-four at the thumb with a neuromuscular transmission monitor. Every value below 90% will be considered as residual paralysis and treated appropriately by means of a reversal agent.

Read the detailed description

Postoperatively, in the ICU, readiness-for-weaning is based on ICU doctor-nurse-driven institutional weaning guidelines: 6 hours after arrival in the ICU, a patient who is normothermic, hemodynamically stable, has normal blood gasses and absence of residual bleeding. The ICU nurse caring for the patient will start weaning the patient from the ventilator, following these departmental guidelines.

02

Conditions studied

  • Postoperative Residual Curarization

Keywords

  • neuromuscular blockade
  • neuromuscular monitoring
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients admitted to the ICU after elective cardiac surgery

Exclusion criteria

Exclusion Criteria:

  • emergency cardiac surgery
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
93 participants (actual)

Interventions

  • Deviceperipheral neuromuscular monitor

    Residual paralysis can only be measured by neuromuscular transmission monitoring of a peripheral nerve, typically the ulnar nerve innervating the adductor pollicis muscle.

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What researchers measure

Primary outcomes

  1. postoperative residual curarisation

    mean train-of-four \<90% as measured by neuromuscular blockade monitoring

    Time frame: 6 hours after arrival in the ICU

06

Study locations

1 site
  • OLV Hospital
    Aalst, 9300, Belgium
07

References and documents

Publications

  • Cammu G. How rational is muscle relaxation during cardiac surgery? Acta Anaesthesiol Belg. 2007;58(1):7-14. PubMed 17486918 ↗
  • Videira RL, Vieira JE. What rules of thumb do clinicians use to decide whether to antagonize nondepolarizing neuromuscular blocking drugs? Anesth Analg. 2011 Nov;113(5):1192-6. doi: 10.1213/ANE.0b013e31822c986e. Epub 2011 Aug 24. PubMed 21865491 ↗
  • Rudis MI, Guslits BG, Zarowitz BJ. Technical and interpretive problems of peripheral nerve stimulation in monitoring neuromuscular blockade in the intensive care unit. Ann Pharmacother. 1996 Feb;30(2):165-72. doi: 10.1177/106002809603000211. PubMed 8835051 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03291184
Lead sponsor
Onze Lieve Vrouw Hospital
Responsible party
Guy CAMMU (MD, PhD, Staff Anesthesiologist, Onze Lieve Vrouw Hospital) — Principal investigator
First posted
Sep 25, 2017
Start date
Sep 4, 2017
Primary completion
Jan 2, 2018
Completion
Mar 8, 2018
Last update
Apr 10, 2018

Study contacts

GUY CAMMU
principal investigator · Onze-Lieve-Vrouw Ziekenhuis Aalst, Belgium

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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