Reducing the Incidence of PostOperative Residual Curarization

Neuromuscular Blockade Clinical Trial

— PORCzero  

Official title:

PORCzero: PostOperative Residual Curarization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03128151
• Other study ID #: CEO-SUG-2016-01
• Status: Completed
• Start date: June 20, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2023
• Source: Hospital Universitario La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2314
• Est. completion date: December 31, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Neuromuscular Blockade

Intervention

Behavioral:
• Educational program for clinicians: implementation of a package of clinical prevention measures of NMB
Intraoperative neuromuscular monitoring and pharmacological reversion of NMB according to data sheet

Locations

Country	Name	City	State
Spain	Hospital la Fe	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
Oscar Diaz-Cambronero	INCLIVA, Instituto de Investigacion Sanitaria La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compliance rate with the bundle of measures	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.	Six months, first three months to evaluate PORC incidence and then three months to evaluate PORC incidence after educational intervention.
Secondary	Rate of intraoperative monitoring	Rate of compliance of clinical prevention measures with intraoperative monitoring.	Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).
Secondary	Rate of reversal of NMBA	Rate of compliance of clinical prevention measures with NMBA reversal after surgery.	Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).
Secondary	Perception of safety -increase- by anesthesiologists	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.	Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).
Secondary	Incidence of postoperative adverse events.	Incidence of postoperative complications in relation to the NMB reversal rate.	Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).