Postoperative Neuromuscular BlockPorceritoNCT06386354
Residual Neuromuscular Block in the Post-Anesthetic Unit and Postoperative Complications
An observational study of Postoperative Neuromuscular Block and Postoperative Complications, run by Hospital Universitario de Gran Canaria Doctor Negrín at 2 sites in Spain.
Trial summary
The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Neuromuscular Block, Postoperative Complications
- What is being tested?
- Train-of-four
- How many people
- 296 participants
- Where
- 2 sitesSpain
- Study dates
- 1 May 2024to 30 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 undergoing surgical intervention under general anesthesia that requires the use of neuromuscular block during the study time.
Who may be able to join
- Patient undergoing surgical intervention under general anesthesia that requires the use of neuromuscular block during the study time and that required hospital admission.
- Informed consent signature.
Who cannot join
- Neuromuscular disease
- Not having received neuromuscular block during the intervention
- Admission to the outpatient surgery unit
- Admission to the postoperative intensive care unit
- Patients who signed informed consent, but postoperative data could not be collected upon arrival at the PACU.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, 35010
Angel Becerra Bolaños, MD PhD, +34928450370, angbecbol@gmail.com
Aurelio E Rodríguez Pérez, MD PhD, +34928450370, arodperp@gobiernodecanarias.org
- Recruiting
Ángel Becerra
Las Palmas de Gran Canaria, Las Palmas, 35019
Ángel Becerra, MD, +34676229025, angbecbol@gmail.com
angbecbol@gmail.com
About this study
The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient.
Read the detailed description
The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient. In this prospective observational study, all patients who underwent general anesthesia with neuromuscular blockade were studied consecutively to evaluate the presence of residual neuromuscular blockade and its potential consequences during hospital admission.Considering that the percentage of residual curarization is 19% (PORCzero study), with a 95% confidence interval and a 3% error margin, 236 patients are needed to accurately estimate the prevalence of residual curarization in the study population. With an expected loss proportion of 20%, the chosen sample size is 296 patients.
- Being tested
- Train-of-four
- Keywords
- General Anesthesia, Neuromuscular block
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Train-of-fourDiagnostic test
Patients submitted to general anesthesia with neuromuscular block will be monitored at their arrival to the Post-Anesthesia Care Unit to assess the presence of residual neuromuscular block.
| Study group | Role | What they receive |
|---|---|---|
| Patients submitted to General Anesthesia with Neuromuscular Block | Patients submitted to General Anesthesia with Neuromuscular Block Receives: Diagnostic Test: Train-of-four |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Neuromuscular Block
Train-Of-Four ratio at arrival to the Post-Anesthetic Care Unit
Measured: 5 minutes postoperatively
Residual Neuromuscular Block
Train-Of-Four ratio 3 minutes after the arrival to the Post-Anesthetic Care Unit
Measured: 8 minutes postoperatively
Secondary outcomes (1)
Postoperative complications
Postoperative complications during hospital admission
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 May 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Neuromuscular BlockStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ángel Becerra-Bolaños, MD PhD, Hospital Universitario de Gran Canaria Doctor Negrín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386354
- Sponsor's protocol ID
- 2023-464-1
- Acronym
- Porcerito
- Status last verified
- Aug 2025
- First submitted
- 23 Apr 2024
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Neuromuscular Block in the Post-Anesthetic Unit and Postoperative Complications
- ClinicalTrials.gov ID
- NCT06386354
- Acronym / sponsor ID
- Porcerito / 2023-464-1
- Keywords
- General Anesthesia, Neuromuscular block
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 26 Apr 2024 (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 use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient.
Detailed description
The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient. In this prospective observational study, all patients who underwent general anesthesia with neuromuscular blockade were studied consecutively to evaluate the presence of residual neuromuscular blockade and its potential consequences during hospital admission.Considering that the percentage of residual curarization is 19% (PORCzero study), with a 95% confidence interval and a 3% error margin, 236 patients are needed to accurately estimate the prevalence of residual curarization in the study population. With an expected loss proportion of 20%, the chosen sample size is 296 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients submitted to General Anesthesia with Neuromuscular Block | – | Diagnostic Test: Train-of-fourPatients submitted to General Anesthesia with Neuromuscular Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgical intervention under general anesthesia that requires the use of neuromuscular block during the study time.
Key inclusion criteria (2 listed)
- Patient undergoing surgical intervention under general anesthesia that requires the use of neuromuscular block during the study time and that required hospital admission.
- Informed consent signature.
Key exclusion criteria (5 listed)
- Neuromuscular disease
- Not having received neuromuscular block during the intervention
- Admission to the outpatient surgery unit
- Admission to the postoperative intensive care unit
- Patients who signed informed consent, but postoperative data could not be collected upon arrival at the PACU.
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 |
|---|---|---|
| Train-of-fourPatients submitted to general anesthesia with neuromuscular block will be monitored at their arrival to the Post-Anesthesia Care Unit to assess the presence of residual neuromuscular block. | Diagnostic test | Patients submitted to General Anesthesia with Neuromuscular Block |
Primary outcome
Residual Neuromuscular Block
Time frame: 5 minutes postoperatively
Train-Of-Four ratio at arrival to the Post-Anesthetic Care Unit
Residual Neuromuscular Block
Time frame: 8 minutes postoperatively
Train-Of-Four ratio 3 minutes after the arrival to the Post-Anesthetic Care Unit
1 secondary outcome
Postoperative complications
Time frame: 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Neuromuscular Block and Postoperative Complications, run by Hospital Universitario de Gran Canaria Doctor Negrín at 2 sites 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ángel Becerra Bolaños, PhD (+34928450370, angbecbol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual Neuromuscular Block (time frame: 5 minutes postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2025.