CClinicalTrials.gg
CompletedNCT03128151PORCzeroUpdated Sep 22, 2023

Reducing the Incidence of PostOperative Residual Curarization

An observational study in Neuromuscular Blockade, sponsored by Oscar Diaz-Cambronero. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-22.

Sponsored by Oscar Diaz-Cambronero · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,314
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Neuromuscular Blockade

Keywords

  • NMB (Neuromuscular Blockade)
  • Anesthesia
  • Curarization
  • TOFr (train of four)
  • PACU (postanesthesia care unit)
  • Monitorization
03

In context

Delayed Emergence from Anesthesia

99 studies on the registry are indexed under Delayed Emergence from Anesthesia; 15 are open to participants now.

This study's enrollment of 2,314 is above the median of 120 across 39 observational studies indexed under Delayed Emergence from Anesthesia.

Browse Delayed Emergence from Anesthesia studies →

Lead sponsor

Oscar Diaz-Cambronero is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,314 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Control group

    Treated according to usual clinical practice

Interventions

  • BehavioralEducational 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

06

What researchers measure

Primary outcomes

  1. 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)).

    Time frame: Six months, first three months to evaluate PORC incidence and then three months to evaluate PORC incidence after educational intervention.

Secondary outcomes

  1. 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.

    Time frame: Six months, first three months to evaluate PORC incidence and then three months to evaluate PORC incidence after educational intervention.

  2. Rate of intraoperative monitoring

    Rate of compliance of clinical prevention measures with intraoperative monitoring.

    Time frame: Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).

  3. Rate of reversal of NMBA

    Rate of compliance of clinical prevention measures with NMBA reversal after surgery.

    Time frame: Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).

  4. 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.

    Time frame: Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).

  5. Incidence of postoperative adverse events.

    Incidence of postoperative complications in relation to the NMB reversal rate.

    Time frame: Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).

07

Study locations

1 site
  • Hospital la Fe
    Valencia, 46026, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03128151
Lead sponsor
Oscar Diaz-Cambronero
Collaborators
Instituto de Investigacion Sanitaria La Fe, INCLIVA
Responsible party
Oscar Diaz-Cambronero (Physician, specialist in Anesthesiology, Hospital Universitario La Fe) — Sponsor-investigator
First posted
Apr 25, 2017
Start date
Jun 20, 2018
Primary completion
Dec 30, 2018
Completion
Dec 31, 2018
Last update
Sep 22, 2023

Study contacts

Oscar Diaz Cambronero, MD
principal investigator · Hospital La Fe

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion