Reducing the Incidence of PostOperative Residual Curarization

NCT03128151 | Completed

• 1 other identifier: CEO-SUG-2016-01
• Study Type: observational
• Target: 2,314
• Locations: 1 country
• Sites: 1

Brief Summary

The NMB (Neuromuscular Blockade) is the most frequent complication in anesthesiology associated with an increase in adverse respiratory events in the postoperative period. Its appearance depends on multiple factors. The introduction of a comprehensive educational strategy aimed at promoting the proper management of NMB in the intraoperative period and a package of measures that must be performed (intraoperative neuromuscular monitoring and reversal of the effect of neuromuscular blockers) may contribute to a decrease in the incidence of NMB, Increase safety in the surgical patient and decrease associated costs.

Conditions

Neuromuscular Blockade

Keywords

NMB (Neuromuscular Blockade); Anesthesia; Curarization; TOFr (train of four); PACU (postanesthesia care unit); Monitorization

Outcome Measures

Primary Outcomes (1)

• Incidence of PORC.

  To reduce the incidence of PORC ≤ 10% by the introduction of an educational program and a bundle of preventive measures (including intraoperative monitoring and reversal of neuromuscular blocking agents (NMBA)).

  Six months, first three months to evaluate PORC incidence and then three months to evaluate PORC incidence after educational intervention.

Secondary Outcomes (5)

• Compliance rate with the bundle of measures

  Six months, first three months to evaluate PORC incidence and then three months to evaluate PORC incidence after educational intervention.

• Rate of intraoperative monitoring

  Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).

• Rate of reversal of NMBA

  Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).

• Perception of safety -increase- by anesthesiologists

  Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).

• Incidence of postoperative adverse events.

  Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).

Study Arms (2)

Study group

Intraoperative neuromuscular monitoring and pharmacological reversion according to data sheet

Behavioral: Educational program for clinicians: implementation of a package of clinical prevention measures of NMB

Control group

Treated according to usual clinical practice

Interventions

Educational program for clinicians: implementation of a package of clinical prevention measures of NMB BEHAVIORAL

Intraoperative neuromuscular monitoring and pharmacological reversion of NMB according to data sheet

Study group

Eligibility Criteria

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

Study Population

Patients submitted to general anesthesia with neuromuscular blockade, extubated before admission to the Post Anesthesia Recovery Unit

You may qualify if:

• Patients older than 18 years.
• Classification of the American Society of Anesthesiologists (ASA I-III).
• Patients with absence of cognitive deficit.
• Informed informed consent prior to surgery

You may not qualify if:

• Negative of the patient to participate in the study
• Patients under the age of 18 or incapable of giving their consent
• ASA IV-V
• Pregnancy or breastfeeding
• Associated neuromuscular disorders
• Diabetes mellitus with diagnosed neuropathy

Sponsors & Collaborators

• Oscar Diaz-Cambronero: lead
• Instituto de Investigacion Sanitaria La Fe: collaborator
• Instituto de Investigacion Sanitaria INCLIVA: collaborator

Study Sites (1)

Hospital la Fe

Valencia, 46026, Spain

Location

Related Publications (1)

• Diaz-Cambronero O, Mazzinari G, Errando CL, Garutti I, Gurumeta AA, Serrano AB, Esteve N, Montanes MV, Neto AS, Hollmann MW, Schultz MJ, Argente Navarro MP; Reducing the Incidence of Post Operative Residual Curarization Zero investigators. An educational intervention to reduce the incidence of postoperative residual curarisation: a cluster randomised crossover trial in patients undergoing general anaesthesia. Br J Anaesth. 2023 Sep;131(3):482-490. doi: 10.1016/j.bja.2023.02.031. Epub 2023 Apr 20.

  PMID: 37087332 DERIVED

Study Officials

• Oscar Diaz Cambronero, MD

  Hospital La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician, specialist in Anesthesiology

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 25, 2017
• Study Start: June 20, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 31, 2018
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

ES (1)