Evaluation of the Tof Cuff for Perioperative Neuromuscular Transmission

NCT ID: NCT03117387

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2020-07-01

Brief Summary

Acceleromyography (AMG) is the most wide spread used method to assess neuromuscular block during anesthesia. However AMG is known to be inaccurate when compared to the gold standard in neuromuscular transmission monitoring, electromyography (EMG). Furthermore when the patients arms require to be positioned next to the body and beneath surgical drapes, AMG measurements are often hindered and inaccurate. The TOF cuff is a new device which measures neuromuscular blockade at the upper arm with a blood pressure cuff. It overcomes the previously mentioned disadvantages of AMG. However, it validity compared to EMG and AMG has not yet fully been investigated.

This study aims to compare the bias, limits of agreement and precision of the Train-of-Four cuff relative to AMG and EMG during recovery of moderate and deep neuromuscular block in patients with normal body mass index and morbidly obese patients.

Conditions

Neuromuscular Blockade

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

moderate neuromuscular block, normal body mass index

Patients with normal BMI (\< 30) who will receive a moderate neuromuscular block (train of four 1-3 twitches)

Measurements of the level of neuromuscular blockade

Intervention Type: DIAGNOSTIC_TEST

Study participant were not prospectively exposed to an intervention. Administration of a moderate or deep neuromuscular blockade is at the discretion of the attending anesthesiologist. Study participants only received diagnostic non-invasive monitoring. In routine clinical care the neuromuscular blockade is monitored non-invasively by either acceleromyography, electromyography or by the TOF-Cuff. In this study participants were monitored by the monitors and were not exposed to any additional risk and no effect of an intervention was assessed in this study.

deep neuromuscular block, normal body mass index

Patients with normal BMI (\< 30) who will receive a deep neuromuscular block (post tetanic count of 1-2 twitches)

Measurements of the level of neuromuscular blockade

Intervention Type: DIAGNOSTIC_TEST

Study participant were not prospectively exposed to an intervention. Administration of a moderate or deep neuromuscular blockade is at the discretion of the attending anesthesiologist. Study participants only received diagnostic non-invasive monitoring. In routine clinical care the neuromuscular blockade is monitored non-invasively by either acceleromyography, electromyography or by the TOF-Cuff. In this study participants were monitored by the monitors and were not exposed to any additional risk and no effect of an intervention was assessed in this study.

moderate neuromuscular block, high body mass index

Patients with high BMI (\> 30) who will receive a moderate neuromuscular block (train of four 1-3 twitches)

Measurements of the level of neuromuscular blockade

Intervention Type: DIAGNOSTIC_TEST

Study participant were not prospectively exposed to an intervention. Administration of a moderate or deep neuromuscular blockade is at the discretion of the attending anesthesiologist. Study participants only received diagnostic non-invasive monitoring. In routine clinical care the neuromuscular blockade is monitored non-invasively by either acceleromyography, electromyography or by the TOF-Cuff. In this study participants were monitored by the monitors and were not exposed to any additional risk and no effect of an intervention was assessed in this study.

deep neuromuscular block, high body mass index

Patients with high BMI (\> 30) who will receive a deep neuromuscular block (post tetanic count of 1-2 twitches)

Measurements of the level of neuromuscular blockade

Intervention Type: DIAGNOSTIC_TEST

Study participant were not prospectively exposed to an intervention. Administration of a moderate or deep neuromuscular blockade is at the discretion of the attending anesthesiologist. Study participants only received diagnostic non-invasive monitoring. In routine clinical care the neuromuscular blockade is monitored non-invasively by either acceleromyography, electromyography or by the TOF-Cuff. In this study participants were monitored by the monitors and were not exposed to any additional risk and no effect of an intervention was assessed in this study.

Interventions

Measurements of the level of neuromuscular blockade

Study participant were not prospectively exposed to an intervention. Administration of a moderate or deep neuromuscular blockade is at the discretion of the attending anesthesiologist. Study participants only received diagnostic non-invasive monitoring. In routine clinical care the neuromuscular blockade is monitored non-invasively by either acceleromyography, electromyography or by the TOF-Cuff. In this study participants were monitored by the monitors and were not exposed to any additional risk and no effect of an intervention was assessed in this study.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• American society of Anesthesiologist Physical Status class I-III
• >18 years of age
• Ability to give oral and written informed consent

Exclusion Criteria

• Known or suspected neuromuscular disorders impairing neuromuscular function;
• Allergies to muscle relaxants, anesthetics or narcotics;
• A (family) history of malignant hyperthermia;
• Women who are or may be pregnant or are currently breast feeding;
• Renal insufficiency, as defined by a glomerular filtration rate < 30 ml/min
• Scheduled for anesthesia without the use of muscle relaxants.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Albert Dahan

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Albert Dahan, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

Leiden University Medical Center

Leiden, South Holland, Netherlands

Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek

The Hague, South Holland, Netherlands

Countries

Netherlands

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P17.050

Identifier Type: -

Identifier Source: org_study_id