Neuromuscular Blockade, ResidualPORCNCT06193213
Incidence of Postoperative Residual Curarization
An observational study of Neuromuscular Blockade, Residual, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
An incomplete postoperative recovery of neuromuscular function (postoperative residual curarization - PORC) represents a common problem in post-anesthesia care units (PACU), potentially exposing the patient to adverse respiratory events. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuromuscular Blockade, Residual
- What is being tested?
- measurement of train of four ratio (TOFR) to assess residual neuromuscolar block
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2024to 31 May 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing surgery under general anesthesia with the use of non-depolarizing neuromuscular blocking agents at intermediate duration of action, to facilitate tracheal intubation and/or for maintaining a condition of myoresolution during surgery
Who may be able to join
- Adult patients aged ≥ 18 years, American Society of Anesthesiologists (ASA) physical status I-III, who have expressed written consent to participate in the study and who will undergo surgery under general anesthesia with the use of non-depolarizing neuromuscular blocking agents at intermediate duration of action, to facilitate tracheal intubation and/or for maintaining a condition of myoresolution during surgery.
Who cannot join
- Patients undergoing emergency surgery, who do not require the administration of non-depolarizing neuromuscular blockers, patients with neuromuscular pathologies, or who require postoperative monitoring in the Intensive Care Unit.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00100
About this study
Official title: Incidence of Postoperative Residual Curarization, a Prospective Observational Study
An incomplete postoperative recovery of neuromuscular function (postoperative residual curarization - PORC) represents a common problem in post-anesthesia care units (PACU), potentially exposing the patient to adverse respiratory events.
Quantitative and objective evaluation of neuromuscular function using the train acceleromyographic method -of-four ratio (TOFR) at the level of the adductor muscle of the thumb represents the best way to minimize this risk after administration of non-depolarizing neuromuscular agents.
Read more
Study endpoints Primary endpoint
- incidence of postoperative residual curarization Secondary endopoints
- number of possible respiratory adverse events during the stay in the PACU and during the hospital stay
- estimation of a logistic regression model to define the risk factors associated with residual curarization
Read the detailed description
Neuromuscular blocking agents are commonly used in clinical anesthetic practice to facilitate tracheal intubation and allow muscle relaxation during surgical interventions.
Anesthesiologist's subjective qualitative assessment of the patient's recovery of muscle strength before extubation is not predictive of adequate neuromuscular recovery even if many surveys conducted at an international level [1,2,3] demonstrate how this modality of evaluation is often used above all due to the not always widespread availability of tools for quantitative monitoring of neuromuscular blockade3.
An incomplete recovery of neuromuscular function at the end of surgery (Postoperative residual curarization - PORC) exposes the patient to potential adverse respiratory events and a Consensus Statement [4] of experts in 2018 suggested a quantitative and objective evaluation of neuromuscular function using the train acceleromyographic method -of-four ratio (TOFR) at the level of the adductor muscle of the thumb represents the best way to minimize this risk after administration of non-depolarizing neuromuscular agents.
In case of TOFR ≤ 0.9, reversal of the neuromuscular block is normally performed with drugs belonging to the class of acetylcholinesterase inhibitors (e.g. neostigmine 0.03-0.05 mg/kg, associated with an antimuscarinic agent such as atropine to counteract the cholinergic effects) or by sugammadex (2 or 4 mg/Kg), a selective antagonist of rocuronium and vecuronium which acts by encapsulating the neuromuscular blocking molecule making it ineffective.
Recurrence of neuromuscular blockade may, however, occur primarily due to mechanisms of redistribution of the muscle relaxant or if insufficient doses of the reversal drug are administered.
- Conditions
- Neuromuscular Blockade, Residual
- Being tested
- measurement of train of four ratio (TOFR) to assess residual neuromuscolar block
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of train of four ratio (TOFR) to assess residual neuromuscolar blockProcedure or surgery
Upon arrival of the spontaneously breathing patient in the Post-Anesthesia Care Unit, a researcher will evaluate the TOFR to detect any residual neuromuscular block using the acceleromyographic method at the level of thumb adductor.2 TOFR measurements will be performed 30 seconds apart. If the difference between the two measurements will be ≤ 0.1, the average value will be considered for the purposes of the analysis. In case of a difference > 0.1, a third measurement will be taken and the average of the two closest results will be considered. If a residual block is detected sugammadex will be administered (2 mg/kg in the case of at least 2 contraction responses to TOF stimulation or 4 mg/kg in the case of no contraction response) to restore normal neuromuscular function , assessed by subsequent TOFR measurement.
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative residual neuromuscular block
evaluation of the incidence of postoperative residual neuromuscular block upon arrival in the post-anesthesia care unit (PACU), defined as a TOFR≤0.9, by acceleromyographic method in interventions in which non-depolarizing neuromuscular blockers with intermediate duration of action were administered at the time of tracheal intubation and/or for maintaining a condition of myoresolution during surgery.
Measured: within 5 minutes from admission in the postoperative care unit
Secondary outcomes (2)
number of respiratory adverse events
Number of any adverse respiratory events that occurred during the stay in the PACU and during the hospital stay. Respiratory adverse events will be defines as episodes of desaturation (SpO2<92%) requiring oxygen supplementation or the finding of atelectasis, pneumonia or pleural effusion of non-cardiac origin found on thoracic imaging tests possibly performed during the hospital stay;
Measured: within 7 days
evaluation of possible risk factors for residual curarization
Estimation of a logistic regression model to define risk factors for residual curarization Will be considered as possible risk factors those reported in the literature : the patient's age, the duration of anesthesia, the type of anesthesia administered (inhalation or totally intravenous), the number of administrations and the total dose of neuromuscular blocker, reversal or not of the neuromuscular blockade, the antagonist drug and the type of neuromuscular blocker used during surgery [7].
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Feb 2024
- Primary completion31 May 2024
- Study completion31 May 2024
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 Blockade, ResidualStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandra Piersanti, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193213
- Sponsor's protocol ID
- 5991
- Acronym
- PORC
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piersanti A, Garra R, Sbaraglia F, Del Vicario M, Lamacchia R, Rossi M. Neuromuscular monitoring and incidence of postoperative residual neuromuscular blockade: a prospective observational study. J Anesth Analg Crit Care. 2025 Jan 28;5(1):5. doi: 10.1186/s44158-025-00226-1.
PubMed 39875976
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postoperative Residual Curarization, a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06193213
- Acronym / sponsor ID
- PORC / 5991
- Conditions
- Neuromuscular Blockade, Residual
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 5 Jan 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.
An incomplete postoperative recovery of neuromuscular function (postoperative residual curarization - PORC) represents a common problem in post-anesthesia care units (PACU), potentially exposing the patient to adverse respiratory events.
Quantitative and objective evaluation of neuromuscular function using the train acceleromyographic method -of-four ratio (TOFR) at the level of the adductor muscle of the thumb represents the best way to minimize this risk after administration of non-depolarizing neuromuscular agents.
Study endpoints Primary endpoint
- incidence of postoperative residual curarization Secondary endopoints
- number of possible respiratory adverse events during the stay in the PACU and during the hospital stay
- estimation of a logistic regression model to define the risk factors associated with residual curarization
Detailed description
Neuromuscular blocking agents are commonly used in clinical anesthetic practice to facilitate tracheal intubation and allow muscle relaxation during surgical interventions.
Anesthesiologist's subjective qualitative assessment of the patient's recovery of muscle strength before extubation is not predictive of adequate neuromuscular recovery even if many surveys conducted at an international level [1,2,3] demonstrate how this modality of evaluation is often used above all due to the not always widespread availability of tools for quantitative monitoring of neuromuscular blockade3.
An incomplete recovery of neuromuscular function at the end of surgery (Postoperative residual curarization - PORC) exposes the patient to potential adverse respiratory events and a Consensus Statement [4] of experts in 2018 suggested a quantitative and objective evaluation of neuromuscular function using the train acceleromyographic method -of-four ratio (TOFR) at the level of the adductor muscle of the thumb represents the best way to minimize this risk after administration of non-depolarizing neuromuscular agents.
In case of TOFR ≤ 0.9, reversal of the neuromuscular block is normally performed with drugs belonging to the class of acetylcholinesterase inhibitors (e.g. neostigmine 0.03-0.05 mg/kg, associated with an antimuscarinic agent such as atropine to counteract the cholinergic effects) or by sugammadex (2 or 4 mg/Kg), a selective antagonist of rocuronium and vecuronium which acts by encapsulating the neuromuscular blocking molecule making it ineffective.
Recurrence of neuromuscular blockade may, however, occur primarily due to mechanisms of redistribution of the muscle relaxant or if insufficient doses of the reversal drug are administered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing surgery under general anesthesia with the use of non-depolarizing neuromuscular blocking agents at intermediate duration of action, to facilitate tracheal intubation and/or for maintaining a condition of myoresolution during surgery
Key inclusion criteria (1 listed)
- Adult patients aged ≥ 18 years, American Society of Anesthesiologists (ASA) physical status I-III, who have expressed written consent to participate in the study and who will undergo surgery under general anesthesia with the use of non-depolarizing neuromuscular blocking agents at intermediate duration of action, to facilitate tracheal intubation and/or for maintaining a condition of myoresolution during surgery.
Key exclusion criteria (1 listed)
- Patients undergoing emergency surgery, who do not require the administration of non-depolarizing neuromuscular blockers, patients with neuromuscular pathologies, or who require postoperative monitoring in the Intensive Care Unit.
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 |
|---|---|---|
| measurement of train of four ratio (TOFR) to assess residual neuromuscolar blockUpon arrival of the spontaneously breathing patient in the Post-Anesthesia Care Unit, a researcher will evaluate the TOFR to detect any residual neuromuscular block using the acceleromyographic method at the level of thumb adductor.2 TOFR measurements will be performed 30 seconds apart. If the difference between the two measurements will be ≤ 0.1, the average value will be considered for the purposes of the analysis. In case of a difference > 0.1, a third measurement will be taken and the average of the two closest results will be considered. If a residual block is detected sugammadex will be administered (2 mg/kg in the case of at least 2 contraction responses to TOF stimulation or 4 mg/kg in the case of no contraction response) to restore normal neuromuscular function , assessed by subsequent TOFR measurement. | Procedure or surgery | – |
Primary outcome
postoperative residual neuromuscular block
Time frame: within 5 minutes from admission in the postoperative care unit
evaluation of the incidence of postoperative residual neuromuscular block upon arrival in the post-anesthesia care unit (PACU), defined as a TOFR≤0.9, by acceleromyographic method in interventions in which non-depolarizing neuromuscular blockers with intermediate duration of action were administered at the time of tracheal intubation and/or for maintaining a condition of myoresolution during surgery.
2 secondary outcomes
number of respiratory adverse events
Time frame: within 7 days
evaluation of possible risk factors for residual curarization
Time frame: 4 months
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 26 Feb 2025.
- Derived from this study: PubMed 39875976Piersanti A, Garra R, Sbaraglia F, Del Vicario M, Lamacchia R, Rossi M. Neuromuscular monitoring and incidence of postoperative residual neuromuscular blockade: a prospective observational study. J Anesth Analg Crit Care. 2025 Jan 28;5(1):5. doi: 10.1186/s44158-025-00226-1.
- Individual participant dataSharing planned: No
Related trials for Neuromuscular Blockade, Residual
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants
Not yet recruitingObservational study
Postoperative Residual Neuromuscular Block and Passive Smoke Exposure in Pediatric Dental Patients
Postoperative Residual Curarization, Neuromuscular Block Prolonged
Not yet recruitingObservational study
Acceleromyography Versus Electromyography for Neuromuscular Recovery Assessment at the End of Surgery
Neuromuscular Blockade, Cholecystectomy
Recruiting
Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function
Residual Neuromuscular Block
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.
Alessandra Piersanti, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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, Residual, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 1 inclusion and 1 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 26 Feb 2025. 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 Italy. 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?
postoperative residual neuromuscular block (time frame: within 5 minutes from admission in the postoperative care unit). 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 NCT06193213, 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 26 Feb 2025.