Sugammadex Dosing: Anaesthesiologist Clinical Perception Versus Quantitative Monitoring

NCT04762420 | Completed

• 1 other identifier: DivinoEspíritoSanto
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Many clinicians continue to rely on subjective evaluation in making decisions about the adequacy of neuromuscular function before tracheal extubation rather than using quantitative monitoring. The aim was to compare the sugammadex dose as suggested by senior anaesthesiologists (SSD) based on clinical experience versus the dose determined by quantitative monitoring (QSD) to determine if the subjective dose was appropriate.

Conditions

Neuromuscular Blockade; Anesthesia; TOF; Curarization, Postoperative Residual

Outcome Measures

Primary Outcomes (1)

• The percentage of patients who would receive an adequate or inadequate (over or under) dose of sugammadex.

  Given the interindividual variability response to neuromuscular block, which makes it difficult to subjectively determine the dose needed, the aim was to compare the sugammadex dose as suggested by senior anaesthesiologists based on clinical experience versus the dose determined by quantitative monitoring to determine if the subjective dose was appropriate.

  3 months

Study Arms (2)

Sugammadex dose as suggested by senior anaesthesiologists (SSD) based on clinical experience.

Other: Dose of sugammadex according to SSD and QSD

Dose of Sugammadex determined by quantitative monitoring (QSD).

Other: Dose of sugammadex according to SSD and QSD

Interventions

Dose of sugammadex according to SSD and QSD OTHER

At the time of pharmacologic reversal of the NMB, both the SSD and QSD, according to portuguese guidelines on the management of the NMB, were recorded. The QSD was then administered to the patient. The SSD was considered appropriate if it was within 10% of the recommended dose for the given depth of NMB, as measured by TOFscan® monitor. The results were analyzed descriptively.

Dose of Sugammadex determined by quantitative monitoring (QSD).; Sugammadex dose as suggested by senior anaesthesiologists (SSD) based on clinical experience.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population was made of 66 individuals, aged 18-75 years who underwent general anesthesia with rocuronium (initial dose 0.6 mg/kg) neuromuscular blockade and subsequent reversal with sugammadex.

You may qualify if:

• Patients aged 18-75 years;
• Above patients who underwent general anesthesia with rocuronium neuromuscular blockade and subsequent reversal with sugammadex.

You may not qualify if:

• American Society of Anesthesiologists physical status V;
• Emergency surgery;
• Hypersensitivity history to rocuronium or sugammadex;
• Severe renal impairment/dialysis;
• Neuromuscular diseases;
• Severe hepatic disease;
• Pre-existing coagulopathies;
• Pregnancy.

Sponsors & Collaborators

• Hospital do Divino Espírito Santo de Ponta Delgada: lead

Study Sites (1)

Hospital do Divino Espírito Santo

Ponta Delgada, 9500-370, Portugal

Location

Related Publications (13)

• Esteves S, Roxo A, Resendes H, Pereira L, Fernandes N, Borges S. Recomendações Portuguesas para a Gestão do Bloqueio Neuromuscular 2017. Rev Soc Port Anestesiol. 2018; 27: 4-52.

  RESULT

• Dutu M, Ivascu R, Tudorache O, Morlova D, Stanca A, Negoita S, Corneci D. Neuromuscular monitoring: an update. Rom J Anaesth Intensive Care. 2018 Apr;25(1):55-60. doi: 10.21454/rjaic.7518.251.nrm.

  PMID: 29756064 RESULT

• Unterbuchner C. Neuromuscular Block and Blocking Agents in 2018. Turk J Anaesthesiol Reanim. 2018 Apr;46(2):75-80. doi: 10.5152/TJAR.2018.200318. Epub 2018 Apr 1. No abstract available.

  PMID: 29744239 RESULT

• Naguib M, Brull SJ, Johnson KB. Conceptual and technical insights into the basis of neuromuscular monitoring. Anaesthesia. 2017 Jan;72 Suppl 1:16-37. doi: 10.1111/anae.13738.

  PMID: 28044330 RESULT

• Cammu G. Sugammadex: Appropriate Use in the Context of Budgetary Constraints. Curr Anesthesiol Rep. 2018;8(2):178-185. doi: 10.1007/s40140-018-0265-6. Epub 2018 Mar 20.

  PMID: 29904285 RESULT

• Ciara Mitchell, Steve Lobaz. An Overview of Sugammadex. ATOTW 332 (2016); 1-6

  RESULT

• Daniel Moi. Residual Neuromuscular Blockade, ATOTW 290 (2013); 1-8

  RESULT

• A. Castagnoli, M. Adversi, G. Innocenti, G.F. Di Nino and R.M. Melotti. Post-Operative Residual Curarization (PORC): A Big Issue for Patients' Safety. Risk Management for the Future - Theory and Cases, 2012, 117-136

  RESULT

• Wycherley AS, Bembridge JL. Monitoring techniques; neuromuscular blockade and depth of anaesthesia. Anaesthesia and intensive care medicine (2017).

  RESULT

• Syed F, Trifa M, Uffman JC, Tumin D, Tobias JD. Monitoring of Sugammadex Dosing at a Large Tertiary Care Pediatric Hospital. Pediatr Qual Saf. 2018 Oct 9;3(5):e113. doi: 10.1097/pq9.0000000000000113. eCollection 2018 Sep-Oct.

  PMID: 30584640 RESULT

• Takazawa T, Katsuyuki M, Sawa T, et al. The current status of sugammadex usage and the occurrence of sugammadex-induced anaphylaxis in Japan. APSF Newsletter 2018;33:1.

  RESULT

• Goltz K, Dambach M, Schlapfer M, Biro P. Non-Feasibility to Estimate the Need for Reversal of Neuromuscular Relaxation from the Applied Rocuronium Dosing Pattern: A Retrospective Analysis of Anaesthesia Records. Turk J Anaesthesiol Reanim. 2018 Feb;46(1):57-61. doi: 10.5152/TJAR.2018.98705. Epub 2018 Feb 1.

  PMID: 30140502 RESULT

• de Boer HD, Carlos RV, Brull SJ. Is lower-dose sugammadex a cost-saving strategy for reversal of deep neuromuscular block? Facts and fiction. BMC Anesthesiol. 2018 Nov 6;18(1):159. doi: 10.1186/s12871-018-0605-6.

  PMID: 30400850 RESULT

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paulo Frias, MD

  Hospital do Divino Espírito Santo de Ponta Delgada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 21, 2021
• Study Start: February 1, 2019
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)