OS NMB Depth Measured by Central and Peripheral Monitor.

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03660891
• Other study ID #: OS NMBcentralperipheral
• Status: Not yet recruiting
• Start date: August 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2020
• Source: AZ Sint-Jan AV
• Contact: Jan Paul Mulier, PhD
• Phone: 003259452490
• Email: jan.mulier[@]azsintjan.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Diagnostic Test:
• measuring neuromuscular block
During anesthesia patients are monitored with two instead of one NMT monitor. the difference in measured TOF-PTC is compared

Locations

Country	Name	City	State
Belgium	Azsintjan	Brugge

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TOF-PTC value	Difference in TOF-PTC measured by two different devices during anesthesia.	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