The Association Between Residual Neuromuscular Block Risk... | NCT06899048

Studies
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio

NCT06899048

Sponsor

Assiut University

Status

Recruiting

Last Update Posted

Mar 27, 2025Actual

Enrollment

91Estimated

Phase

Not provided

Conditions

Muscle Relaxants

Interventions

residual neuromuscular block risk prediction score

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2024Actual

Primary Completion Date

Oct 1, 2025Estimated

Completion Date

Apr 1, 2026Estimated

First Submitted Date

Mar 21, 2025

First Submission Date that Met QC Criteria

Mar 26, 2025

First Posted Date

Mar 27, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2025

Last Update Posted Date

Mar 27, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

91Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
residual neuromuscular block risk prediction score	Diagnostic Test	it is a clinical tool designed to estimate the likelihood of residual neuromuxcular blockade in postoperative patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlation between residual neuromuscular block risk prediction score and train of four		1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age group 18-65 years old
Both genders
Patients with American Society of Anesthesiologist physical status classification of 1 or 2.

Exclusion Criteria:

Patients who are less than 18 years old or more than 65 years old.
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.
Patients on medications that interfere with muscle activity.
Known allergy to neuromuscular blocking agents.
Pregnancy or suspected pregnancy.
Neuro-muscular diseases.
Patients refusing to participate in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud A Faisal, Dr	Contact	01004391577	020	dr_mahmoudfaisal@aun.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University Hospitals	Recruiting	Asyut		71111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009123	Muscle Hypotonia

Ancestor Terms

ID	Term
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided