Residual ParalysisNCT06796777
Residual Paralysis in the Post Anesthesia Care Unit: the Association Beetween Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio. a Prospective Single-Center Open-Label Cohort Study
An observational study of Residual Paralysis, run by Assiut University.
Trial summary
The reported incidence of rNMB varies between 16% to more than 70 depending on the used definition (train-of-four [TOF] ratio 0.7 or 0.9), type of NMBA, type of reversal agent, and timing of measurements The degree of residual paralysis can be evaluated in different ways: clinical tests requiring the patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Residual Paralysis
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 May 2027
- 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 who will be scheduled to undergo elective surgical procedures requiring the use of neuromuscular blocking drugs.
Who may be able to join
- 1- Age group 18-65 years old 2- Both genders 3- Patients who will be scheduled to undergo elective surgical procedures requiring the use of neuromuscular blocking drugs.
- 5- Patients with American Society of Anesthesiologist physical status classification of 1 or 2.
Who cannot join
- 1- Patients who are less than 18 years old or more than 65 years old. 2- Patients with planned scheduled recovery in the intensive care unit or if more than 10 minutes had elapsed since tracheal extubation until NMB monitoring at the PACU.
- 3- Patients on medications that interfere with muscle activity. 4- Known allergy to neuromuscular blocking agents. 5- Pregnancy or suspected pregnancy. 6- Neuro-muscular diseases. 7- Patients refusing to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The reported incidence of rNMB varies between 16% to more than 70 depending on the used definition (train-of-four [TOF] ratio 0.7 or 0.9), type of NMBA, type of reversal agent, and timing of measurements The degree of residual paralysis can be evaluated in different ways: clinical tests requiring the patients cooperation, which normally can be performed only after emergence; visual or tactile evaluation of responses to TOF or double-burst stimulation (DBS) at the adductor pollicis (qualitative or subjective assessment); and measurement of the TOF ratio (TOFr) with a device (quantitative or objective measurement), For several years, the standard criterion for adequate neuromuscular function recovery was a TOF ratio of 0.7 Residual paralysis risk prediction score (REPS) has been recently invented to identify surgical patients who might be at an increased risk for the development of rNMB. Ten independent predictors for residual paralysis were identified and used for the score development.
Recent literature reported that REPS ≥4 is significantly associated with an increased risk of postoperative respiratory complications when neuromuscular monitoring is not used Does of reverse is neostigmine(.04-.08)mg/kg and does of Atropine .01mg /kg Time of surgical intervention not affecte measurement of residual paralysis in PACU the aim of the study evaluate the degree of association, and the predictive accuracy of the REPS (as a predictive tool) compared with the TOFr as a quantitative assessment tool for (rNMB) in surgical patients in the early postoperative phase. The TOFr will be measured at 0, 15, 30, 45, and 60 min after extubation.
Read the detailed description
The reported incidence of rNMB varies between 16% to more than 70 depending on the used definition (train-of-four [TOF] ratio 0.7 or 0.9), type of NMBA, type of reversal agent, and timing of measurements The degree of residual paralysis can be evaluated in different ways: clinical tests requiring the patients cooperation, which normally can be performed only after emergence; visual or tactile evaluation of responses to TOF or double-burst stimulation (DBS) at the adductor pollicis (qualitative or subjective assessment); and measurement of the TOF ratio (TOFr) with a device (quantitative or objective measurement), For several years, the standard criterion for adequate neuromuscular function recovery was a TOF ratio of 0.7 Residual paralysis risk prediction score (REPS) has been recently invented to identify surgical patients who might be at an increased risk for the development of rNMB. Ten independent predictors for residual paralysis were identified and used for the score development.
Recent literature reported that REPS ≥4 is significantly associated with an increased risk of postoperative respiratory complications when neuromuscular monitoring is not used Does of reverse is neostigmine(.04-.08)mg/kg and does of Atropine .01mg /kg Time of surgical intervention not affecte measurement of residual paralysis in PACU the aim of the study evaluate the degree of association, and the predictive accuracy of the REPS (as a predictive tool) compared with the TOFr as a quantitative assessment tool for (rNMB) in surgical patients in the early postoperative phase. The TOFr will be measured at 0, 15, 30, 45, and 60 min after extubation.
- Conditions
- Residual Paralysis
- Keywords
- Residual Neuromuscular Block Risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who will be scheduled to undergo elective surgical procedures requiring the use of neuromus | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of residual neuromascular block
the incidence of rNMB assessed by train-of-four ratio at admission to the PACU and at 15, 30, 45, and 60 min after PACU admission to be correlated with the Risk Prediction Score
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Residual ParalysisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Mostafa kamel Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796777
- Sponsor's protocol ID
- NMB RPS Train four ratio
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Paralysis in the Post Anesthesia Care Unit: the Association Beetween Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio. a Prospective Single-Center Open-Label Cohort Study
- ClinicalTrials.gov ID
- NCT06796777
- Acronym / sponsor ID
- NMB RPS Train four ratio
- Conditions
- Residual Paralysis
- Keywords
- Residual Neuromuscular Block Risk
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 28 Jan 2025 (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 reported incidence of rNMB varies between 16% to more than 70 depending on the used definition (train-of-four [TOF] ratio 0.7 or 0.9), type of NMBA, type of reversal agent, and timing of measurements The degree of residual paralysis can be evaluated in different ways: clinical tests requiring the patients cooperation, which normally can be performed only after emergence; visual or tactile evaluation of responses to TOF or double-burst stimulation (DBS) at the adductor pollicis (qualitative or subjective assessment); and measurement of the TOF ratio (TOFr) with a device (quantitative or objective measurement), For several years, the standard criterion for adequate neuromuscular function recovery was a TOF ratio of 0.7 Residual paralysis risk prediction score (REPS) has been recently invented to identify surgical patients who might be at an increased risk for the development of rNMB. Ten independent predictors for residual paralysis were identified and used for the score development.
Recent literature reported that REPS ≥4 is significantly associated with an increased risk of postoperative respiratory complications when neuromuscular monitoring is not used Does of reverse is neostigmine(.04-.08)mg/kg and does of Atropine .01mg /kg Time of surgical intervention not affecte measurement of residual paralysis in PACU the aim of the study evaluate the degree of association, and the predictive accuracy of the REPS (as a predictive tool) compared with the TOFr as a quantitative assessment tool for (rNMB) in surgical patients in the early postoperative phase. The TOFr will be measured at 0, 15, 30, 45, and 60 min after extubation.
Detailed description
The reported incidence of rNMB varies between 16% to more than 70 depending on the used definition (train-of-four [TOF] ratio 0.7 or 0.9), type of NMBA, type of reversal agent, and timing of measurements The degree of residual paralysis can be evaluated in different ways: clinical tests requiring the patients cooperation, which normally can be performed only after emergence; visual or tactile evaluation of responses to TOF or double-burst stimulation (DBS) at the adductor pollicis (qualitative or subjective assessment); and measurement of the TOF ratio (TOFr) with a device (quantitative or objective measurement), For several years, the standard criterion for adequate neuromuscular function recovery was a TOF ratio of 0.7 Residual paralysis risk prediction score (REPS) has been recently invented to identify surgical patients who might be at an increased risk for the development of rNMB. Ten independent predictors for residual paralysis were identified and used for the score development.
Recent literature reported that REPS ≥4 is significantly associated with an increased risk of postoperative respiratory complications when neuromuscular monitoring is not used Does of reverse is neostigmine(.04-.08)mg/kg and does of Atropine .01mg /kg Time of surgical intervention not affecte measurement of residual paralysis in PACU the aim of the study evaluate the degree of association, and the predictive accuracy of the REPS (as a predictive tool) compared with the TOFr as a quantitative assessment tool for (rNMB) in surgical patients in the early postoperative phase. The TOFr will be measured at 0, 15, 30, 45, and 60 min after extubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who will be scheduled to undergo elective surgical procedures requiring the use of neuromus | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will be scheduled to undergo elective surgical procedures requiring the use of neuromuscular blocking drugs.
Key inclusion criteria (2 listed)
- 1- Age group 18-65 years old 2- Both genders 3- Patients who will be scheduled to undergo elective surgical procedures requiring the use of neuromuscular blocking drugs.
- 5- Patients with American Society of Anesthesiologist physical status classification of 1 or 2.
Key exclusion criteria (2 listed)
- 1- Patients who are less than 18 years old or more than 65 years old. 2- Patients with planned scheduled recovery in the intensive care unit or if more than 10 minutes had elapsed since tracheal extubation until NMB monitoring at the PACU.
- 3- Patients on medications that interfere with muscle activity. 4- Known allergy to neuromuscular blocking agents. 5- Pregnancy or suspected pregnancy. 6- Neuro-muscular diseases. 7- Patients refusing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the incidence of residual neuromascular block
Time frame: 60 minutes
the incidence of rNMB assessed by train-of-four ratio at admission to the PACU and at 15, 30, 45, and 60 min after PACU admission to be correlated with the Risk Prediction Score
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 28 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Residual Paralysis
Active, not recruitingObservational study
Predicting Neuromuscular Recovery in Surgical Patients Using Machine Learning
Residual Paralysis, Post Anesthesia, Postoperative Complications
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Residual Paralysis, run by Assiut University.
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 2 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: opening soon, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Hossam Mostafa kamel Mohamed, residant doctor (+201208953385, Hossammostafa.98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of residual neuromascular block (time frame: 60 minutes). 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 28 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.