Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-03 @ 7:58 AM
Study NCT ID:
NCT03052894
Status:
TERMINATED
Last Update Posted:
2019-12-17
First Post:
2017-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Muscle Relaxation Monitor
Sponsor:
Richard H Epstein
Organization:
Study Overview
Official Title:
Validation of a Device to Monitor Muscle Relaxation During Surgery
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Data collection issues from the electronic health record.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to determine the accuracy of a hydraulically coupled twitch monitor compared to the EMG twitch monitor in current use to measure the extent of neuromuscular blockade in patients undergoing general anesthesia.
Detailed Description:
Neuromuscular blockade (paralysis) is necessary for many surgical procedures to provide optimal surgical conditions. The extent of paralysis typically assessed during routine clinical care by examining the muscle response of the thumb ("twitch") following delivery of a series of the "train-of-four".
Quantitative assessment of neuromuscular block can be assessed using electromyography (EMG) This technique measures action potential in the muscles of the thumb.
The proposed method is a simple technique that can constructed with equipment that is readily available in most operating rooms. If validated, it would provide a simple method to assess quantitatively the extent of neuromuscular blockade and recovery of muscle strength.
Quantitative assessment of neuromuscular block can be assessed using electromyography (EMG) This technique measures action potential in the muscles of the thumb.
The proposed method is a simple technique that can constructed with equipment that is readily available in most operating rooms. If validated, it would provide a simple method to assess quantitatively the extent of neuromuscular blockade and recovery of muscle strength.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: