Postoperative Residual Paralysis After Cardiac Surgery

NCT ID: NCT03291184

Last Updated: 2018-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-04

Study Completion Date

2018-03-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Residual Curarization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients admitted to the ICU after elective cardiac surgery and ready for weaning from the ventilator.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators
The participant will still be under sedation at the moment of measuring neuromuscular blockade. The care provider will perform measurements, while the investigator is blinded.

Interventions

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peripheral 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients admitted to the ICU after elective cardiac surgery

Exclusion Criteria

* emergency cardiac surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Onze Lieve Vrouw Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guy CAMMU

MD, PhD, Staff Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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GUY CAMMU

Role: PRINCIPAL_INVESTIGATOR

Onze-Lieve-Vrouw Ziekenhuis Aalst, Belgium

Locations

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OLV Hospital

Aalst, , Belgium

Site Status

Countries

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Belgium

References

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Cammu G. How rational is muscle relaxation during cardiac surgery? Acta Anaesthesiol Belg. 2007;58(1):7-14.

Reference Type BACKGROUND
PMID: 17486918 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21865491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8835051 (View on PubMed)

Other Identifiers

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EN_GC_2017

Identifier Type: -

Identifier Source: org_study_id

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