Clinical trial NCT06796777: 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
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Residual Paralysis
Keywords: Residual Neuromuscular Block Risk
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who will be scheduled to undergo elective surgical procedures requiring the use of neuromuscular blocking drugs.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: the incidence of residual neuromascular block
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: