Clinical trial NCT03128151: Reducing the Incidence of PostOperative Residual Curarization
Official title: PORCzero: PostOperative Residual Curarization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Keywords: NMB (Neuromuscular Blockade)
Anesthesia
Curarization
TOFr (train of four)
PACU (postanesthesia care unit)
Monitorization
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
Collaborators: name: Instituto de Investigacion Sanitaria La Fe
name: INCLIVA
First posted: 2017-04-25
Enrollment: 2314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients submitted to general anesthesia with neuromuscular blockade, extubated before admission to the Post Anesthesia Recovery Unit

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of PORC.
timeFrame: Six months, first three months to evaluate PORC incidence and then three months to evaluate PORC incidence after educational intervention.
Secondary outcomes:
measure: Compliance rate with the bundle of measures
timeFrame: Six months, first three months to evaluate PORC incidence and then three months to evaluate PORC incidence after educational intervention.
measure: Rate of intraoperative monitoring
timeFrame: Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).
measure: Rate of reversal of NMBA
timeFrame: Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).
measure: Perception of safety -increase- by anesthesiologists
timeFrame: Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).
measure: Incidence of postoperative adverse events.
timeFrame: Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital la Fe
Study officials:
affiliation: Hospital La Fe
name: Oscar Diaz Cambronero, MD
role: PRINCIPAL_INVESTIGATOR
References: