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.

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

Study Overview

• Status: Unknown
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Diagnostic test: measuring neuromuscular block

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Azsintjan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients undergo a laparoscopic surgery and require a deep NMB.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Principal Investigator: Jan Paul Mulier, AZSint Jan AV

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: August 19, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: OS NMBcentralperipheral

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No