Algorithm of Muscle Function Tests to Detect Residual Neuromuscular Blockade.

University of Regensburg (UR)

Status: Completed

Conditions: Postoperative Residual Curarization

Treatments: Device: Acceleromyography

Study type: Interventional

Funder types: Other

Identifiers

NCT03219138

N° 1783/ 07

Details and patient eligibility

About

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

Full 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.

Enrollment: 265 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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265 participants in 2 patient groups

Electromyography

No Intervention group

Description:

Neuromuscular function was monitored, using evoked electromyography of the adductor pollicis muscle with a neuromuscular transmission module by a non-blinded investigator.

Acceleromyography

Experimental group

Description:

Immediately after extubation the blinded anaesthesiologist tested with an uncalibrated acceleromyography on the contralateral arm.

Treatment:

Device: Acceleromyography