Postoperative Residual Curarization in 2018

November 13, 2018 updated by: Guy CAMMU, Onze Lieve Vrouw Hospital

Neuromuscular Monitoring, Reversal of Block and Postoperative Residual Curarization: the Situation in 2018

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

587

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • OLV Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onze Lieve Vrouw Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2018

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

November 12, 2018

Study Registration Dates

First Submitted

September 7, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 11, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LKGC2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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