- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02433769
Acceleromyographic Assessment of Neuromuscular Blockade: TOF-Watch-SX Versus TOFscan
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
30 patients presenting for elective surgical procedures with an expected duration greater than 60 minutes will be enrolled in this study. ASA I to III patients requiring neuromuscular blockade in the operating room will be eligible for enrollment. All neuromuscular management will be conducted as recommended by the Good Clinical Research Practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents guidelines
Monitoring will consist of standard ASA monitors, which include manual blood pressure measurements, continuous EKG monitoring, pulse oximetry, capnography, and infrared gas analysis. The placement of the TOFscan to the dominant or non-dominant hand will be determined using a computer-generated randomization table. The TOF-Watch-SX will be placed on the other hand.
Anesthetic induction will be as per usual routine clinical care, consisting of propofol 2.0-2.5 mg/kg and fentanyl 100 μg; rocuronium 0.6 mg/kg will be given over 5 seconds through a fast-running IV after baseline neuromuscular data are collected. General anesthesia will be maintained with sevoflurane 1.0-3.0%, with the concentration of inhalational agent adjusted to maintain blood pressure within 20% of baseline values. The depth of anesthesia will also be adjusted to maintain Bispectral Index (BIS monitor) values between 40-60, as per usual clinical practice. Core temperature will be maintained > 35°C and hand temperature > 32°C using an upper extremity warming blanket. Additional doses of rocuronium can be administered (5-10 mg) if required for surgical relaxation (a TOF count of 2-3 during TOF stimulation). No NMBAs will be administered during the last 20 minutes of the procedure. At the completion of surgery, neuromuscular blockade will be reversed with neostigmine 50 µg/kg plus glycopyrrolate, per usual standard of care.
Upon arrival to the operating room, neuromuscular monitoring surface electrodes will be applied. All monitoring will be conducted while the patient is under general anesthesia for the surgical procedure. Surface electrodes (non-invasive EKG electrodes) will be placed on the cleansed skin over the ulnar nerve of both arms near the wrist. The electrodes will be connected by leads to the nerve stimulator component of the TOF-Watch-SX on one arm and the TOFscan on the other arm. The transducer (AMG sensor which measures acceleration) of the TOF-Watch-SX will be placed on the thumb of the corresponding hand. A 75-150g preload (via the Hand adapter) will be applied as per standard recommendations. On the other hand, the transducer (three-dimensional AMG sensor) of the TOFscan will be placed on the thumb using the integrated hand adapter. During the surgical procedure, both devices will be activated simultaneously, and the responses to nerve stimulation recorded.
After induction of anesthesia, but before administration of rocuronium, calibration and stable baseline signals will be achieved for the TOF-Watch-SX and the TOFscan as suggested by the Good Clinical Research Guidelines. After the baseline data are collected, the neuromuscular blocking agent (rocuronium) will be administered. Data relating to onset (a TOF ratio decreases from 1.0 to 0.3 or less on the TOF-Watch-SX display), maintenance (the TOF ratio is less than 0.3 and constant on the TOF-Watch-SX display), and reversal (an increase in the TOF ratio from 0.2 to 0.9 or above) will be recorded. At these same times, data from the TOFscan will be recorded. Monitoring will continue until full recovery of neuromuscular function is noted (a TOF ratio of at least 0.9 or greater on the TOF-Watch-SX device display). At this time, the anesthesia agents will be turned off and the patient awakened and extubated. After surgery, data recorded simultaneously from the TOF-Watch-SX and the TOFscan will be compared.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Illinois
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Evanston, Illinois, United States, 60201
- NorthShore University Healthsystem
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA I to III patients requiring neuromuscular blockade in the operating room
Exclusion Criteria:
- presence of an underlying neuromuscular disease
- use of drugs known to interfere with neuromuscular transmission (antiseizure medications, anticholinesterases, magnesium sulfate)
- presence of renal or hepatic disease
- procedures preventing access to both of the upper extremities.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: TOf-Watch-SX
Train-of-four (TOF) ratios will be measured with the TOF-Watch-SX and compared to TOF ratios measured simultaneously with the TOFscan
|
Data from the TOF-Watch-SX will be compared to simultaneously measured data from the TOFscan
|
Experimental: TOFscan
Train-of-four (TOF) ratios obtained from the TOFscan will be compared to TOF ratios measured simultaneously with the TOF-Watch-SX
|
Data from the TOFscan will be compared to simultaneously measured data from the TOF-Watch-SX ("gold standard")
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Train-of-four (TOF) ratio 0.7
Time Frame: from the start of surgery until 1 hour after admission to the recovery room
|
Data from the TOFscan will be compared to the TOF-Watch-SX at a TOF ratio of 0.7 (when the TOF-Watch-SX reads 0.7 (gold standard), the reading from the TOFscan will be recorded and compared
|
from the start of surgery until 1 hour after admission to the recovery room
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Train-of-four (TOF) ratio 0.6
Time Frame: from the start of surgery until 1 hour after admission to the recovery room
|
Data from the TOFscan will be compared to the TOF-Watch-SX at a TOF ratio of 0.6 (when the TOF-Watch-SX reads 0.6 (gold standard), the reading from the TOFscan will be recorded and compared
|
from the start of surgery until 1 hour after admission to the recovery room
|
train-of-four (TOF) ratio 0.9
Time Frame: from the start of surgery until 1 hour after admission to the recovery room
|
Data from the TOFscan will be compared to the TOF-Watch-SX at a TOF ratio of 0.9 (when the TOF-Watch-SX reads 0.9 (gold standard), the reading from the TOFscan will be recorded and compared
|
from the start of surgery until 1 hour after admission to the recovery room
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EH14-266
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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