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Clinical Trials/NCT03219138
NCT03219138
Completed
Not Applicable

Development of an Algorithm Using Clinical Tests to Avoid Post-operative Residual Neuromuscular Block

University of Regensburg5 sites in 1 country265 target enrollmentJanuary 8, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Residual Curarization
Sponsor
University of Regensburg
Enrollment
265
Locations
5
Primary Endpoint
Clinical muscle function tests
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Objective neuromuscular monitoring is the gold standard to detect postoperative residual curarization (PORC). Many anesthesiologist just use qualitative neuromuscular monitoring or unreliable, clinical tests. Goal of this study is to develop an algorithm of muscle function tests to identify PORC

Detailed Description

Background: Quantitative neuromuscular monitoring is the gold standard to detect postoperative residual curarization (PORC). Many anesthesiologists, however, use insensitive, qualitative neuromuscular monitoring or unreliable, clinical tests. Goal of this multicentre, prospective, double-blinded, assessor controlled study is to develop an algorithm of muscle function tests to identify PORC. Methods: After extubation a blinded anesthetist performs eight clinical tests in 165 patients. Test results are correlated to calibrated electromyography train-of-four (TOF) ratio and to a postoperatively applied uncalibrated acceleromyography. A classification and regression tree (CART) is calculated developing the algorithm to identify PORC. This is validated against uncalibrated acceleromyography and tactile judgement of TOF fading in separate 100 patients.

Registry
clinicaltrials.gov
Start Date
January 8, 2008
End Date
July 25, 2009
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christoph Unterbuchner

Principal Investigator

University of Regensburg

Eligibility Criteria

Inclusion Criteria

  • The patients were scheduled for elective low risk surgical procedures:
  • laparoscopic abdominal procedures
  • orthopedic
  • minor visceral surgery

Exclusion Criteria

  • participation in another study
  • body mass index over 30
  • history of neuromuscular diseases
  • gastro-esophageal reflux disease.

Outcomes

Primary Outcomes

Clinical muscle function tests

Time Frame: Muscle function tests are performed immediately after extubation.

Measurement of postoperative residual curarisation with clinical muscle function test: * time able to open the eyes * appearence of diplopic images * time able to stick out the tongue * spatula pressure test * time able to lift the head * time able to lift the arm * strength of the patient pressing the investigator's hand * ability to swallow 20 ml of water

Secondary Outcomes

  • Uncalibrated acceleromyography(Uncalibrated acceleromyography is measured immediately after extubation.)
  • Qualitative neuromuscular measurement(Qualitative acceleromyography is measured immediately after extubation.)

Study Sites (5)

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