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Completed

NCT Number: NCT03128151

Reducing the Incidence of PostOperative Residual Curarization

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.

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Key information

Conditions

Neuromuscular Blockade

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital la Fe

Valencia, 46026, Spain

About this study

Multicenter, epidemiological, prospective, randomized, sequential study. The introduction of an educational program and a package of clinical measures (specific monitoring and pharmacological reversion) in the incidence of NMB will be evaluated by evaluating variations in this incidence of NMB, the rate of compliance with the preventive measures and the perception of the Safety in the perioperative, through pre and postoperative survey.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Incidence of PORC.

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

    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)).

Secondary outcomes

  1. Compliance rate with the bundle of measures

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

    To evaluate if the educational program increases compliance of clinical preventive measures, if the reduction of incidence of BNMR is maintained, and, in addition, if this compliance is maintained over time.

  2. Rate of intraoperative monitoring

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

    Rate of compliance of clinical prevention measures with intraoperative monitoring.

  3. Rate of reversal of NMBA

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

    Rate of compliance of clinical prevention measures with NMBA reversal after surgery.

  4. Perception of safety -increase- by anesthesiologists

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

    To evaluate, from the point of view of patient safety, whether the perception of safety by clinicians is maintained, through a survey before and after the intervention.

  5. Incidence of postoperative adverse events.

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

    Incidence of postoperative complications in relation to the NMB reversal rate.

Sponsors and collaborators

Lead sponsor

Oscar Diaz-Cambronero

Other

Collaborators

  • Instituto de Investigacion Sanitaria INCLIVA
  • Instituto de Investigacion Sanitaria La Fe

Registry information

Official study title

PORCzero: PostOperative Residual Curarization

Acronym: PORCzero

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 25, 2017
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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