OS NMB Depth Measured by Central and Peripheral Monitor.

• Conditions: Neuromuscular Blockade

• Registration Number: NCT03660891
• Lead Sponsor: AZ Sint-Jan AV

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

Study Timeline

• Study First Submitted: 2018-08-19
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-07
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-20
• Last Update Posted: 2020-03-23
• Study Start: 2020-08-01
• Primary Completion: 2020-12-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TOF-PTC value	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.

Trial Locations

Locations (1)

Azsintjan; 🇧🇪 Brugge, Belgium