Reducing the Incidence of PostOperative Residual Curarization

Completed

• Conditions: Neuromuscular Blockade

• Registration Number: NCT03128151
• Lead Sponsor: Oscar Diaz-Cambronero

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.

Study Timeline

• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-25
• Study Start: 2018-06-20
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2314

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of PORC.	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 Outcome Measures

Name	Time	Method
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.	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	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	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	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.	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.

Trial Locations

Locations (1)

Hospital la Fe; 🇪🇸 Valencia, Spain