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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

Tracking Information
First Submitted Date September 7, 2018
First Posted Date September 11, 2018
Last Update Posted Date November 14, 2018
Actual Study Start Date July 30, 2018
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 7, 2018)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03665805 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Postoperative Residual Curarization in 2018
Official Title Neuromuscular Monitoring, Reversal of Block and Postoperative Residual Curarization: the Situation in 2018
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Postoperative Residual Curarization
Intervention 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).
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 13, 2018)
587
Original Estimated Enrollment
 (submitted: September 7, 2018)
600
Actual Study Completion Date November 12, 2018
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT03665805
Other Study ID Numbers LKGC2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Guy CAMMU, Onze Lieve Vrouw Hospital
Study Sponsor Onze Lieve Vrouw Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Onze Lieve Vrouw Hospital
Verification Date November 2018