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.
1 other identifier
observational
20
1 country
1
Brief Summary
Comparing during anesthesia in the same patient 2 neuromuscular monitors on the same arm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2018
CompletedFirst Posted
Study publicly available on registry
September 7, 2018
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMarch 23, 2020
March 1, 2020
5 months
August 19, 2018
March 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
During anesthesia patients are monitored with two instead of one NMT monitor. the difference in measured TOF-PTC is compared
Eligibility Criteria
all patients undergo a laparoscopic surgery and require a deep NMB.
You may qualify if:
- laparoscopic surgery of upper abdomen including all types of bariatric surgery.
You may not qualify if:
- upper arm obesity excluding the use of an upper arm blood pressure cuff
- allergy to NMB (neuromuscular blockers)
- contra indication for a deep NMB
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AZ Sint-Jan AVlead
Study Sites (1)
Azsintjan
Bruges, 8000, Belgium
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Paul Mulier
AZSint Jan AV
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
August 19, 2018
First Posted
September 7, 2018
Study Start
August 1, 2020
Primary Completion
December 30, 2020
Study Completion
December 31, 2021
Last Updated
March 23, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share