Reducing the Incidence of PostOperative Residual Curarization (PORCzero)

September 21, 2023 updated by: Oscar Diaz-Cambronero

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2314

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Valencia, Spain, 46026
        • Hospital la Fé

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of PORC.
Time Frame: 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)).
Six months, first three months to evaluate PORC incidence and then three months to evaluate PORC incidence after educational intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compliance rate with the bundle of measures
Time Frame: 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.
Six months, first three months to evaluate PORC incidence and then three months to evaluate PORC incidence after educational intervention.
Rate of intraoperative monitoring
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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.
Time Frame: 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.
Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oscar Diaz-Cambronero

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto de Investigacion Sanitaria La Fe
INCLIVA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Oscar Diaz Cambronero, MD, Hospital la Fé

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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