Interest of the Automated Management of Deep Neuromuscular Blockade Monitoring (CURATP)

Neuromuscular Blockade Clinical Trial

— CURATP  

Official title:

Interest of the Automated Management of Deep Neuromuscular Blockade Monitoring : A Pilot Pre-post Quasi Experimental Study (CURATP)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05784610
• Other study ID #: CURATP
• Secondary ID: 2022-A01929-34
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: May 2023

Study information

• Verified date: March 2023
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Neuromuscular blockade (NMB) recommendations updated in 2018 by the Société Française d'Anesthésie et Réanimation (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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients will be included if they meet all the following criteria :

• Age = 18 years

• Scheduled Abdominal surgery by laparoscopy (digestive, urological and gynaecological) with a planned procedure duration of more than one hour, requiring deep NMB by rocuronium

• ASA I, II or III

• Free subject, without guardianship, curatorship or subordination

• Signed informed consent

Exclusion Criteria:

• Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.

• Induction in rapid sequence,

• Use of an other NMB agent than rocuronium

• Predictable difficult intubation

• Persons participating in another clinical trial

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Device:
• Monitorage by TOF/PTC
Installation of TOFscan® and monitoring by MAR appreciation on one of the patient's wrists and installation of TOFscan® and monitoring by ATP mode (MAR blind) on the other wrist Installation of TOFscan® and monitoring by ATP mode
• Monitorage by ATP
Installation of TOFscan® and monitoring by ATP mode on one of the patient's wrists

Locations

Country	Name	City	State
France	Centre Hospitalier de Poitiers	Poitiers	Vienne

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

References & Publications (14)

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 Cl — View Citation

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/s00268-016-3 — View Citation

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/a — View Citation

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. — View Citation

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.000000000 — View Citation

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 anaesth — View Citation

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 — View Citation

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 — View Citation

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 — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 = 1 and = 5 responses	From intubation to surgical closure
Secondary	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
Secondary	Amount of NMB agents administered	Total dose of NMB agents administered in mg/kg/h during the surgical procedure	From intubation to surgical closure
Secondary	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
Secondary	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
Secondary	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