Reducing the Incidence of PostOperative Residual Curarization (PORCzero)

PORCzero: 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.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Behavioral: Educational program for clinicians: implementation of a package of clinical prevention measures of NMB

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 Type: Observational
• Enrollment (Actual): 2314

Contacts and Locations

• Study Contact: Name: Oscar Diaz-Cambronero, MD; Phone Number: 412296 961244000; Email: perioperativemedicine@iislafe.es

Study Locations

• Spain
  • Valencia, Spain, 46026
    • Hospital La Fe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients submitted to general anesthesia with neuromuscular blockade, extubated before admission to the Post Anesthesia Recovery Unit

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Intraoperative neuromuscular monitoring and pharmacological reversion according to data sheet	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
Control group; Treated according to usual clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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).
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).
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).
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).

Collaborators and Investigators

• Sponsor: Oscar Diaz-Cambronero
• Collaborators: Instituto de Investigacion Sanitaria La Fe; INCLIVA
• Investigators: Principal Investigator: Oscar Diaz Cambronero, MD, Hospital La Fe

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2018
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Anesthesia; PACU (postanesthesia care unit); Monitorization; Curarization; NMB (Neuromuscular Blockade); TOFr (train of four)
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia
• Other Study ID Numbers: CEO-SUG-2016-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No