Neuromuscular Monitoring:TOFCuff Versus EMG
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|ClinicalTrials.gov Identifier: NCT04282213|
Recruitment Status : Recruiting
First Posted : February 24, 2020
Last Update Posted : May 1, 2020
|Condition or disease|
Neuromuscular relaxation of the patient during surgery is necessary for multiple reasons, such as facilitating intubation or improving the effectiveness of some surgical procedures. Premature extubation of the patient without having achieved a complete recovery of the NMB can have deleterious consequences, increasing postoperative complications, especially those related to the respiratory system. Given this, current guidelines of good clinical practice recommend the monitoring of pharmacologically induced NMB during general anesthesia. In addition, monitoring allows confirmation of optimum relaxation before intubation, and allows for control over re-dose administration and recovery of NMB upon awakening from general anesthesia.
There are different methods of quantitative monitoring of NMB. The TOF-CUFF monitor uses a method based on a traditional pressure cuff that incorporates stimulation electrodes. The placement of the cuff which aligns the stimulation electrodes on the path of the brachial plexus at the humeral level allows to evaluate the muscular response evoked from the changes in the cuff pressure, generated by the muscular contraction after the electrical stimulus. Its main advantage is that monitoring of the NMB is included within the pressure cuff itself, which is always used in any anesthetic act. Then, when the pressure cuff is placed, monitoring of the NMB is easily established. This specific design facilitates the task of anesthesiologists because they do not have to perform any additional preparation for the monitoring of NMB.
The TOF-CUFF monitor has been validated regarding the mechanomyography, which is considered the gold-standard for the monitoring of NMB. The main objective of the study is to compare the values of NMB measured with the TOF-CUFF monitor with NMB values measured with the CARESCAPE B450 monitor during the pharmacologically induced NMB and evaluate the degree of equivalence in different situations. Secondary objective is to verify that the design for joint monitoring of the NMB and NIBP in the TOF-CUFF monitor does not affect the independent measure of the two variables.
Prospective, single-center, open and controlled observational clinical study. The study is aimed to be conducted with 40 patients aged between 18 and 65 years.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Comparison of the TOFCuff Monitor Versus Electromyography in Neuromuscular Monitoring|
|Actual Study Start Date :||January 15, 2020|
|Estimated Primary Completion Date :||May 10, 2020|
|Estimated Study Completion Date :||May 10, 2020|
For each case, neuromuscular measurements gathered with GE CARESCAPE B450 monitor (E-NMT module).
For each case, neuromuscular measurements gathered with TOFCuff monitor.
- TOFR (Train Of Four Ratio) [ Time Frame: Baseline ]
For this measurement, patient is stimulated with four twitches at a known stimulation current. Each twitch is performed every 500ms. The neuromuscular response for each twitch is gathered. Train Of Four ratio consists of the weighting of the fourth stimulus against the first stimulus.
It can be calculated also as a percentage.
- Counts [ Time Frame: Baseline ]When performing the Train Of Four (TOF) measurement, count of the twitches that are higher than 0.
- PTC [ Time Frame: Baseline ]
Once patient is in a deep neuromuscular blockade, all twitches from Train Of Four (TOF) measurement are 0. In order to evaluate the neuromuscular response, Post Tetanic Count (PTC) measurement is performed.
PTC is splitted in two steps. First, during 5 seconds a tetanic stimulation is performed at 50Hz. If no response is elicited, after a pause of 3 seconds 15 single-twitch stimualtion at 1Hz are performed. PTC value is the count of the single-twitches that are higher than 0.
- T1 [ Time Frame: Baseline ]For Train Of Four (TOF) measurement, amplitude of the first neuromuscular stimulation response. Units depend on the measurement techniques.
- T2 [ Time Frame: Baseline ]For Train Of Four (TOF) measurement, amplitude of the second neuromuscular stimulation response. Units depend on the measurement techniques.
- T3 [ Time Frame: Baseline ]For Train Of Four (TOF) measurement, amplitude of the third neuromuscular stimulation response. Units depend on the measurement techniques.
- T4 [ Time Frame: Baseline ]For Train Of Four (TOF) measurement, amplitude of the fourth neuromuscular stimulation response. Units depend on the measurement techniques.
- PID [ Time Frame: Baseline ]Diastolic pressure in mmHg
- PIS [ Time Frame: Baseline ]Systolic pressure in mmHg
- PIM [ Time Frame: Baseline ]Mean pressure in mmHg
- Temperature [ Time Frame: Baseline ]Patient temperature on the palm hand
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282213
|Contact: Lorena Silva Gil, MDfirstname.lastname@example.org|
|Centro Médico Teknon||Recruiting|
|Barcelona, Spain, 08022|
|Contact: Lorena Silva Gil, MD 932906005 email@example.com|
|Sub-Investigator: Carlos Rafael Ramírez Paesano, MD|
|Sub-Investigator: Ferran Callicó Ros, Eng|
|Sub-Investigator: Sara Julián González, MSc|
|Principal Investigator:||Lorena Silva Gil, MD||Servei d'Anestesiologia Centro Médico Teknon|