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OS NMB Depth Measured by Central and Peripheral Monitor.

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03660891
Enrollment
20
Registered
2018-09-07
Start date
2020-08-01
Completion date
2021-12-31
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade

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

Interventions

DIAGNOSTIC_TESTmeasuring neuromuscular block

During anesthesia patients are monitored with two instead of one NMT monitor. the difference in measured TOF-PTC is compared

Sponsors

AZ Sint-Jan AV
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
TOF-PTC valueFrom induction of anesthesia (intubation with ETT) till end of anesthesia (extubation of ETT) most frequent between 1 and 2 hours, max 6 hours in durationDifference in TOF-PTC measured by two different devices during anesthesia.

Countries

Belgium

Contacts

Primary ContactJan Paul Mulier, PhD
jan.mulier@azsintjan.be003259452490
Backup ContactKris Leleu, MD
003250452490

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026