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Medications used to relax the muscles are used during surgery. The amount of muscle relaxation can monitored with devices that stimulate a specific nerve and evaluate the muscle response. The response to, and recovery from, medications that relax the muscles are best described for a nerve in the arm called the ulnar nerve. The investigators believe that other nerves in the arm, such as the median nerve, could be used to monitor the amount of muscle relaxation. The purpose of this study is to compare the muscle response at two different nerve sites after giving medications to relax the muscles.
This study is going to measure the depth of muscle relaxation during surgery at two different sites. The muscle response to stimulation of the ulnar nerve (located in the arm) will be compared to the muscle response to stimulation of the median nerve (also located in the arm).
This is a single-center prospective, randomized controlled trial comparing ulnar versus median nerve electromyography transmission.
Neuromuscular blockade is used to provide muscle relaxation during surgery. The depth of neuromuscular blockade can be monitored with nerve stimulation or electromyography. The response to and recovery from non-depolarizing neuromuscular blockade is best described for the ulnar nerve. The investigators postulate that the median nerve may provide comparable information about the response non-depolarizing neuromuscular blockade. Electromyography electrodes will be positioned to stimulate the ulnar nerve in one arm and the median nerve in the other arm. The response to, and recovery from, non-depolarizing neuromuscular blockade will be compared between the ulnar and median nerve.
The location of median nerve monitoring will be randomized to the dominant or non-dominant hand.
The randomized arm will have electrodes positioned to stimulate the median nerve and the other arm will have electrodes positioned to stimulate the ulnar nerve (standard site for monitoring neuromuscular transmission during anesthesia).
The purpose of the study is to compare the response to, and recovery from, non-depolarizing neuromuscular blockade between the ulnar and median nerves.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Patients Receiving Non-Depolarizing Neuromuscular Blockade | Surgical patients having surgery that requires muscle relaxation with non-depolarizing neuromuscular blockers and monitoring of the depth of muscle blockade.The muscle response to nerve stimulation will be compared between the ulnar and median nerve. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular Transmission Monitoring | Device | A neuromuscular transmission module connected to electrodes applied to the skin and positioned to provide stimulation of a single nerve and monitor the muscular response to nerve stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Neuromuscular transmission nerve monitoring concordance | The length of time between rocuronium administration and first post-tetanic twitch for both nerves | Change in time between administration of rocuronium at beginning of surgery and the appearance of one post-tetanic twitch on a monitor, typically 20 minutes after sedation |
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of median nerve neuromuscular monitoring compared to ulnar nerve neuromuscular monitoring - first train of four | Time from rocuronium administration to the patient having 1 Train-of-Four twitch after appearance of first post-tetanic twitch, on both monitors | Change in time between administration of rocuronium at beginning of surgery and the appearance of the first Train-of-Four twitch on a monitor, typically 30 minutes after appearance of post-tetanic twitch |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for elective surgery at Loma Linda University Medical Center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa D McCabe, MD, MSCR | Contact | 909 558 4475 | 44475 | mmccabe@llu.edu |
| Michael Benggon, MD | Contact | 909 558 4475 | 44475 | mbenggon@llu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Benggon, MD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Troesch Medical Center | Recruiting | Loma Linda | California | 92354 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35061641 | Background | Iwasaki H, Yamamoto M, Sato H, Doshu-Kajiura A, Kitajima O, Takagi S, Luthe SK, Suzuki T. A Comparison Between the Adductor Pollicis Muscle Using TOF-Watch SX and the Abductor Digiti Minimi Muscle Using TetraGraph in Rocuronium-Induced Neuromuscular Block: A Prospective Observational Study. Anesth Analg. 2022 Aug 1;135(2):370-375. doi: 10.1213/ANE.0000000000005897. Epub 2022 Jan 21. | |
| 31044121 |
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| Non-inferiority of median nerve neuromuscular monitoring compared to ulnar nerve neuromuscular monitoring - second train of four | Time from rocuronium administration to the patient having 2 Train-of-Four twitches after appearance of first Train-of-Four twitch, on both monitors | Change in time between administration of rocuronium at beginning of surgery and the appearance of the first instance of 2 Train-of-Four twitches on a monitor, typically 30 minutes after appearance of first train-of-four twitch |
| Non-inferiority of median nerve neuromuscular monitoring compared to ulnar nerve neuromuscular monitoring - reversal | Time from reversal at 2 or more Train-of-Four twitches with sugammadex administration to the patient having a Train-of-Four ratio greater than or equal to 0.9, or 90 percent, on both monitors | Change in time between administration of sugammadex at end of surgery and the appearance of a Train-of-Four ratio greater than or equal to 0.9 on a monitor, typically 5 minutes after sugammadex administration |
| Background |
| Ortiz R, Westenberg RF, Langhammer CG, Knaus WJ, Chen NC, Eberlin KR. Nerve Diameter in the Hand: A Cadaveric Study. Plast Reconstr Surg Glob Open. 2019 Mar 13;7(3):e2155. doi: 10.1097/GOX.0000000000002155. eCollection 2019 Mar. |
| 19933538 | Background | Duvaldestin P, Kuizenga K, Saldien V, Claudius C, Servin F, Klein J, Debaene B, Heeringa M. A randomized, dose-response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia. Anesth Analg. 2010 Jan 1;110(1):74-82. doi: 10.1213/ANE.0b013e3181c3be3c. Epub 2009 Nov 21. |
| 21716963 | Background | Lee HJ, Kim KS, Shim JC, Yoon SW. A comparison of the accuracy of ulnar versus median nerve stimulation for neuromuscular monitoring. Korean J Anesthesiol. 2011 May;60(5):334-8. doi: 10.4097/kjae.2011.60.5.334. Epub 2011 May 31. |
| 31617199 | Background | Bowdle A, Bussey L, Michaelsen K, Jelacic S, Nair B, Togashi K, Hulvershorn J. A comparison of a prototype electromyograph vs. a mechanomyograph and an acceleromyograph for assessment of neuromuscular blockade. Anaesthesia. 2020 Feb;75(2):187-195. doi: 10.1111/anae.14872. Epub 2019 Oct 16. |