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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A01929-34 | Registry Identifier | ID-RCB |
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Neuromuscular blockade (NMB) recommendations updated in 2018 by the SociƩtƩ FranƧaise d'AnesthƩsie et RƩanimation (SFAR) recommend the use of NMB agents to facilitate surgical procedure during abdominal surgery by laparotomy or laparoscopy.
This study aims to evaluate deep NMB monitoring with automated management of NMB depth measurement (ATP mode) versus non-automated monitoring (PTC/TOF), in order to improve the maintenance of deep NMB during abdominal surgery.
The beneficial effects of deep NMB on the surgical conditions and thus the per and post operative surgical morbidity have been demonstrated in several studies, but the evidence are not yet consistent enough to make recommendations.
The monitoring of per operative NMB remains the rule, using the Train Of Four (TOF) at the ulnar nerve at the adductor of the thumb. However, when deep NMB for the most resistant muscles of the body is required (diaphragm and abdominal wall), the Post Tetanic Count (PTC) should be used.
In order to better adjust the NMB to the conditions of muscle relaxation required during surgery, an automatic mode called ATP for Automatic TOF/PTC has been developed (TofScan, Idmed, Marseille, France).
The investigators hypothesized that the use of the ATP would be able to better insure deep NMB, and to limit interventions on patients and/or on the NMB monitor during surgical procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOF/PTC | Active Comparator | Non-automated neuromuscular blockade monitoring (TOF/PTC). As the NMB monitoring is depending on anesthesiologist usual practice and so only TOF measure is systematic, it is necessary to include a blind anesthesiologist measurement with the ATP mode in order to compare with data obtained during Time 2. |
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| ATP | Experimental | Automated neuromuscular blockade monitoring (ATP). TOF and PTC stimulations are regularly performed, and PTC is systematically performed if TOF = 0/4. If PTC = 10/10, a TOF stimulation is automatically performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monitorage by TOF/PTC | Device | Installation of TOFscanĀ® and monitoring by MAR appreciation on one of the patient's wrists and installation of TOFscanĀ® and monitoring by ATP mode (MAR blind) on the other wrist Installation of TOFscanĀ® and monitoring by ATP mode |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the monitoring of deep NMB by automated management of the measurement of depth NMB (ATP mode) compared to non-automated monitoring (PTC/TOF) in order to improve the maintenance of deep NMB during abdominal surgery | Percentage of time spent on deep NMB target during anesthesia, defined by PTC ā„ 1 and ā¤ 5 responses | From intubation to surgical closure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of interventions by the anesthesia team to maintain deep curarization | Number of NMB agents reinjections and interventions on the NMB monitor by the anesthesia team, per hour, during the procedure | From intubation to surgical closure |
| Amount of NMB agents administered |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MATTHIEU M BOISSON, Professor | University Center Hospital of Poitiers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Poitiers | Poitiers | Vienne | 86021 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20996123 | Result | GRAY TC, HALTON J. Technique for the use of d-tubocurarine chloride with balanced anaesthesia. Br Med J. 1946 Aug 31;2:293-5. No abstract available. | |
| 4313564 | Result | Ali HH. A new device for monitoring force of thumb adduction. Br J Anaesth. 1970 Jan;42(1):83-5. doi: 10.1093/bja/42.1.83. No abstract available. |
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Time 1: Non-automated neuromuscular blockade monitoring (TOF/PTC). As the NMB monitoring is depending on anesthesiologist usual practice and so only TOF measure is systematic, it is necessary to include a blind anesthesiologist measurement with the ATP mode in order to compare with data obtained during Time 2.
Time 2: Automated neuromuscular blockade monitoring (ATP). TOF and PTC stimulations are regularly performed, and PTC is systematically performed if TOF = 0/4
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Masking only for the anesthesist in arms "Time 1"
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| Monitorage by ATP | Device | Installation of TOFscanĀ® and monitoring by ATP mode on one of the patient's wrists |
|
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Total dose of NMB agents administered in mg/kg/h during the surgical procedure |
| From intubation to surgical closure |
| Need to reverse NMB agents at the end of the procedure | Number of patients requiring NMB reversal with prostigmine or sugammadex | From intubation to surgical closure |
| Effect of maintaining deep NMB at surgical level during the procedure | Maximum intra-abdominal pressure of insufflation in mmHg recorded during surgical procedure | From intubation to surgical closure |
| Surgical conditions on the Leiden Surgical Rating Scale score | Surgical conditions will be measured using a translated French version of the Leiden Surgical Rating Scale ( L-SRS ), a likert scale from 1 "extremely poor conditions" to 5 "optimal conditions" | From intubation to surgical closure |
| 17561516 | Result | Dhonneur G, Kirov K, Motamed C, Amathieu R, Kamoun W, Slavov V, Ndoko SK. Post-tetanic count at adductor pollicis is a better indicator of early diaphragmatic recovery than train-of-four count at corrugator supercilii. Br J Anaesth. 2007 Sep;99(3):376-9. doi: 10.1093/bja/aem124. Epub 2007 Jun 7. |
| 26582847 | Result | Kim HJ, Lee K, Park WK, Lee BR, Joo HM, Koh YW, Seo YW, Kim WS, Yoo YC. Deep neuromuscular block improves the surgical conditions for laryngeal microsurgery. Br J Anaesth. 2015 Dec;115(6):867-72. doi: 10.1093/bja/aev368. |
| 24977638 | Result | Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Lindekaer AL, Riber C, Gatke MR. Surgical space conditions during low-pressure laparoscopic cholecystectomy with deep versus moderate neuromuscular blockade: a randomized clinical study. Anesth Analg. 2014 Nov;119(5):1084-92. doi: 10.1213/ANE.0000000000000316. |
| 24240315 | Result | Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15. |
| 25789421 | Result | Madsen MV, Gatke MR, Springborg HH, Rosenberg J, Lund J, Istre O. Optimising abdominal space with deep neuromuscular blockade in gynaecologic laparoscopy--a randomised, blinded crossover study. Acta Anaesthesiol Scand. 2015 Apr;59(4):441-7. doi: 10.1111/aas.12493. Epub 2015 Mar 1. |
| 26945393 | Result | Kim MH, Lee KY, Lee KY, Min BS, Yoo YC. Maintaining Optimal Surgical Conditions With Low Insufflation Pressures is Possible With Deep Neuromuscular Blockade During Laparoscopic Colorectal Surgery: A Prospective, Randomized, Double-Blind, Parallel-Group Clinical Trial. Medicine (Baltimore). 2016 Mar;95(9):e2920. doi: 10.1097/MD.0000000000002920. |
| 25684372 | Result | Van Wijk RM, Watts RW, Ledowski T, Trochsler M, Moran JL, Arenas GW. Deep neuromuscular block reduces intra-abdominal pressure requirements during laparoscopic cholecystectomy: a prospective observational study. Acta Anaesthesiol Scand. 2015 Apr;59(4):434-40. doi: 10.1111/aas.12491. Epub 2015 Feb 13. |
| 27405749 | Result | Koo BW, Oh AY, Seo KS, Han JW, Han HS, Yoon YS. Randomized Clinical Trial of Moderate Versus Deep Neuromuscular Block for Low-Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy. World J Surg. 2016 Dec;40(12):2898-2903. doi: 10.1007/s00268-016-3633-8. |
| 26317357 | Result | Yoo YC, Kim NY, Shin S, Choi YD, Hong JH, Kim CY, Park H, Bai SJ. The Intraocular Pressure under Deep versus Moderate Neuromuscular Blockade during Low-Pressure Robot Assisted Laparoscopic Radical Prostatectomy in a Randomized Trial. PLoS One. 2015 Aug 28;10(8):e0135412. doi: 10.1371/journal.pone.0135412. eCollection 2015. |
| 31926308 | Result | Plaud B, Baillard C, Bourgain JL, Bouroche G, Desplanque L, Devys JM, Fletcher D, Fuchs-Buder T, Lebuffe G, Meistelman C, Motamed C, Raft J, Servin F, Sirieix D, Slim K, Velly L, Verdonk F, Debaene B. Guidelines on muscle relaxants and reversal in anaesthesia. Anaesth Crit Care Pain Med. 2020 Feb;39(1):125-142. doi: 10.1016/j.accpm.2020.01.005. Epub 2020 Jan 8. |
| 30130260 | Result | Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur M, Benson J, Newmark RL, Maher CE. Comparison of the TOFscan and the TOF-Watch SX during Recovery of Neuromuscular Function. Anesthesiology. 2018 Nov;129(5):880-888. doi: 10.1097/ALN.0000000000002400. |
| 20595196 | Result | Claudius C, Skovgaard LT, Viby-Mogensen J. Arm-to-arm variation when evaluating neuromuscular block: an analysis of the precision and the bias and agreement between arms when using mechanomyography or acceleromyography. Br J Anaesth. 2010 Sep;105(3):310-7. doi: 10.1093/bja/aeq162. Epub 2010 Jun 30. |