Clinical Trial: Reducing the Incidence of PostOperative Residual Curarization

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: PORCzero: PostOperative Residual Curarization

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.

Detailed Summary: 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.
Sponsor: Oscar Diaz-Cambronero

Current Primary Outcome: 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)).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Hospital Universitario La Fe

Dates:
Date Received: April 10, 2017
Date Started: June 20, 2017
Date Completion: June 20, 2018
Last Updated: April 25, 2017
Last Verified: April 2017