Acceleromyographic Assessment of Neuromuscular Blockade: TOF-Watch-SX Versus TOFscan
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02433769|
Recruitment Status : Unknown
Verified April 2017 by Glenn S. Murphy, MD, NorthShore University HealthSystem.
Recruitment status was: Active, not recruiting
First Posted : May 5, 2015
Last Update Posted : April 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neuromuscular Blockade||Device: TOFscan Device: TOF-Watch-SX||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acceleromyographic Assessment of Neuromuscular Blockade: TOF-Watch-SX Versus TOFscan|
|Actual Study Start Date :||April 2015|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||May 2017|
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
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")
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433769
|United States, Illinois|
|NorthShore University HealthSystem|
|Evanston, Illinois, United States, 60201|