Neuromuscular BlockadePORCzeroNCT03128151
Reducing the Incidence of PostOperative Residual Curarization
An observational study of Neuromuscular Blockade, run by Oscar Diaz-Cambronero at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Educational program for clinicians: implementation of a package of clinical prevention measures of NMB
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,314 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jun 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients submitted to general anesthesia with neuromuscular blockade, extubated before admission to the Post Anesthesia Recovery Unit
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Neuromuscular Blockade
- Being tested
- Educational program for clinicians: implementation of a package of clinical prevention measures of NMB
- Keywords
- NMB (Neuromuscular Blockade), Anesthesia, Curarization, TOFr (train of four), PACU (postanesthesia care unit), Monitorization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational program for clinicians: implementation of a package of clinical prevention measures of NMBBehavioural
Intraoperative neuromuscular monitoring and pharmacological reversion of NMB according to data sheet
| Study group | Role | What they receive |
|---|---|---|
| Study group | Intraoperative neuromuscular monitoring and pharmacological reversion according to data sheet Receives: Behavioral: Educational program for clinicians: implementation of a package of clinical prevention measures of NMB | |
| Control group | Treated according to usual clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: Six months, first three months to evaluate PORC incidence and then three months to evaluate PORC incidence after educational intervention.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Six months, from the beginning, with no intervention, until the end of phase III (end of recruitment in both groups).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start20 Jun 2018
- Primary completion30 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oscar Diaz-Cambronero
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria La Fe, Instituto de Investigacion Sanitaria INCLIVA
- Responsible party
- Sponsor-investigator, Oscar Diaz-Cambronero, Hospital Universitario La Fe
- Investigators
- Oscar Diaz Cambronero, MD, Principal investigator, Hospital La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128151
- Sponsor's protocol ID
- CEO-SUG-2016-01
- Acronym
- PORCzero
- Status last verified
- Sep 2023
- First submitted
- 10 Apr 2017
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Diaz-Cambronero O, Mazzinari G, Errando CL, Garutti I, Gurumeta AA, Serrano AB, Esteve N, Montanes MV, Neto AS, Hollmann MW, Schultz MJ, Argente Navarro MP; Reducing the Incidence of Post Operative Residual Curarization Zero investigators. An educational intervention to reduce the incidence of postoperative residual curarisation: a cluster randomised crossover trial in patients undergoing general anaesthesia. Br J Anaesth. 2023 Sep;131(3):482-490. doi: 10.1016/j.bja.2023.02.031. Epub 2023 Apr 20.
PubMed 37087332
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PORCzero: PostOperative Residual Curarization
- ClinicalTrials.gov ID
- NCT03128151
- Acronym / sponsor ID
- PORCzero / CEO-SUG-2016-01
- Conditions
- Neuromuscular Blockade
- Keywords
- NMB (Neuromuscular Blockade), Anesthesia, Curarization, TOFr (train of four), PACU (postanesthesia care unit), Monitorization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,314 participants (actual)
- Lead sponsor
- Oscar Diaz-CambroneroUniversity, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria La Fe, Instituto de Investigacion Sanitaria INCLIVA
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Behavioral: Educational program for clinicians: implementation of a package of clinical prevention measures of NMBIntraoperative neuromuscular monitoring and pharmacological reversion according to data sheet |
| Control group | – | –Treated according to usual clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients submitted to general anesthesia with neuromuscular blockade, extubated before admission to the Post Anesthesia Recovery Unit
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational program for clinicians: implementation of a package of clinical prevention measures of NMBIntraoperative neuromuscular monitoring and pharmacological reversion of NMB according to data sheet | Behavioural | Study group |
Primary outcome
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)).
5 secondary outcomes
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.
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 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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Derived from this study: PubMed 37087332Diaz-Cambronero O, Mazzinari G, Errando CL, Garutti I, Gurumeta AA, Serrano AB, Esteve N, Montanes MV, Neto AS, Hollmann MW, Schultz MJ, Argente Navarro MP; Reducing the Incidence of Post Operative Residual Curarization Zero investigators. An educational intervention to reduce the incidence of postoperative residual curarisation: a cluster randomised crossover trial in patients undergoing general anaesthesia. Br J Anaesth. 2023 Sep;131(3):482-490. doi: 10.1016/j.bja.2023.02.031. Epub 2023 Apr 20.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar Diaz Cambronero, MD principal investigator
Hospital La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade, run by Oscar Diaz-Cambronero at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03128151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.