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Postoperative Residual Curarization in 2018

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ClinicalTrials.gov Identifier: NCT03665805
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Guy CAMMU, Onze Lieve Vrouw Hospital

Brief Summary:
The primary objective of this study is to evaluate the incidence of postoperative residual curarization, as defined by a train-of-four <90%, upon postanaesthesia care unit arrival. Anesthetists tend to use train-of-four monitoring in the operating theatre to interpret muscle tone. Train-of-four monitoring is a widely used term for the peripheral nerve stimulation used in neuromuscular blockade monitoring. Hypothesizing a change in our practice since 2006-2012 (Cammu G, Anesth Analg 2006; 102: 426-9 and Cammu G, Anaesth Intensive Care 2012; 40: 999-1006), residual neuromuscular block as well as the use of intraoperative neuromuscular transmission monitoring and reversal of neuromuscular blocking agents will again be prospectively evaluated in 2018. The present study aims to compare these three periods (2006-2012-2018) in terms of management of neuromuscular block in the operating room and to look for a relationship with the incidence of postoperative residual curarization.

Condition or disease Intervention/treatment
Postoperative Residual Curarization Other: neuromuscular transmission monitoring

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Study Type : Observational
Actual Enrollment : 587 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neuromuscular Monitoring, Reversal of Block and Postoperative Residual Curarization: the Situation in 2018
Actual Study Start Date : July 30, 2018
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : November 12, 2018

Intervention Details:
  • Other: neuromuscular transmission monitoring
    The acceleromyographic responses of the adductor pollicis muscle as percent of the train-of-four (TOF%) on stimulation of the ulnar nerve by means of the TOFscan neuromuscular transmission monitor (iDMed, Marseille, France).


Primary Outcome Measures :
  1. Incidence of postoperative residual curarisation [ Time Frame: Immediately after the patients' arrival in the post-anesthesia care unit (<5 min after arrival), two consecutive neuromuscular transmission measurements (separated by 15 s) will be obtained, and the average of the 2 values will be recorded. ]
    Incidence of postoperative residual curarisation defined by a train-of-four (TOF) ratio < 0,9 at post-anesthesia care unit arrival



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
About 600 surgical patients (the first 600 inpatients and outpatients scheduled for anesthesia during the study period who meet the study criteria).
Criteria

Inclusion Criteria:

  • 18 years of age or older;
  • Informed consent signed;
  • Admission for elective surgery;
  • Administration of non-depolarizing neuromuscular blocking agents during surgery;
  • Tracheal intubation

Exclusion Criteria:

  • Evidence of renal, hepatic, metabolic, and/or neuromuscular disorders
  • Ejection fraction <20%
  • Admission for emergency surgery; or cardiothoracic surgery
  • Reoperation during the same hospital admission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665805


Locations
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Belgium
OLV Hospital
Aalst, Belgium, 9300
Sponsors and Collaborators
Onze Lieve Vrouw Hospital

Publications:
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Responsible Party: Guy CAMMU, Staff Anesthesiologist, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier: NCT03665805     History of Changes
Other Study ID Numbers: LKGC2018
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guy CAMMU, Onze Lieve Vrouw Hospital:
Muscle Relaxation

Additional relevant MeSH terms:
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Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes