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

January 22, 2025 updated by: Hossam Mostafa kamel Mohamed, Assiut University

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 Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

91

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

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who will be scheduled to undergo elective surgical procedures requiring the use of neuromuscular blocking drugs.

Description

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • 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

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
Patients who will be scheduled to undergo elective surgical procedures requiring the use of neuromus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 minutes

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMB RPS Train four ratio

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

product manufactured in and exported from the U.S.

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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