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Clinical Trials/NCT03660891
NCT03660891
Unknown
Not Applicable

Observational Study Measuring Neuromuscular Block Depth by a TOF or PTC Monitor on the Thumb and on the Upper Arm of the Same Side.

AZ Sint-Jan AV1 site in 1 country20 target enrollmentAugust 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuromuscular Blockade
Sponsor
AZ Sint-Jan AV
Enrollment
20
Locations
1
Primary Endpoint
TOF-PTC value
Last Updated
6 years ago

Overview

Brief Summary

Comparing during anesthesia in the same patient 2 neuromuscular monitors on the same arm.

Detailed Description

NMT (neuromuscular transmission) depth can be measured at the same arm with two different methods during clinical practice. the first (TOF Watch) measures the musculus adductor pollicis acceleration while the second method (TOF Cuff Monitor) uses a blood pressure cuff to measure the pressure changes induced by the upper arm muscles. During general anesthesia when NMB (neuromuscular block) is required both methods are used. Every 5 minutes, if clinical required, the NMB is monitored by TOF-PTC. If the measurement of TOF is zero the monitor continues by measuring PTC ( the system will measure TOF followed by PTC if TOF is zero) TOF-PTC is recorded and later compared for identity or systematic difference in one or the other direction. The measured answer can be TOF 4 (4 answers) with a ratio between answer 1 and 4 expressed and a percentage, TOF 3 (3 answers), TOF 2, TOF 1, TOF 0 + PTC 20, TOF 0 + PTC 19, up to TOF 0 + PTC 0

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
December 31, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jan Mulier

principle investigator

AZ Sint-Jan AV

Eligibility Criteria

Inclusion Criteria

  • all patients scheduled for an elective surgery requiring neuromuscular block during anesthesia
  • laparoscopic surgery of upper abdomen including all types of bariatric surgery.

Exclusion Criteria

  • not possible to measure NMT (neuromuscular transmission) by cuff or thumb monitor
  • upper arm obesity excluding the use of an upper arm blood pressure cuff
  • allergy to NMB (neuromuscular blockers)
  • contra indication for a deep NMB

Outcomes

Primary Outcomes

TOF-PTC value

Time Frame: From induction of anesthesia (intubation with ETT) till end of anesthesia (extubation of ETT) most frequent between 1 and 2 hours, max 6 hours in duration

Difference in TOF-PTC measured by two different devices during anesthesia.

Study Sites (1)

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