Residual Vocal Cords Curarization Correlation Between Clinical and Ultrasound Endpoints

NCT06283329 | Completed

• 1 other identifier: echographic VC curarization
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Through recent studies residual curarization (RC) remains frequent but serious event, that could be easily avoided in the presence of a paraclinical monitoring and by antagonization of curares. However, conventional monitors focus only on peripheral muscles, whereas ultrasonography allows direct visualization of laryngeal muscles, particularly the vocal cords, which are directly influenced by neuromuscular blocking agents. The aim of the study was to evaluate the ultrasound mobility of the vocal cords after awakening and extubation of general anesthesia compared to their preoperative mobility and its correlation with clinical and paraclinical diagnostic criteria (DG) for RC.

Conditions

Residual Curarization

Keywords

residual curarization; airway access; echography

Outcome Measures

Primary Outcomes (1)

• Echographic mobility of vocal cords at different times in post extubation

  measured in TM mode, mobility will be measured in millimeters from baseline curve

  before induction (T0), immediately after extubation (T1) and 30 minutes after extubation (T2)

Study Arms (2)

Group A

a group of patients receiving systematic decurarization using neostigmine , a unique dose of 40 µg/kg associated with atropine 20 µg/kg

Diagnostic Test: vocal cords echography

Group B

a group of patients extubated through clinical criteria without use of neostigmine

Diagnostic Test: vocal cords echography

Interventions

vocal cords echography DIAGNOSTIC_TEST

Ultrasound assessments of the amplitude of the vocal cords movement were performed on a sagittal median section of the arytenoid cartilages with a 30° inclination using a Golf Head ultrasound probe at 3 different time points: before induction (T0), after extubation (T1), in recovery room 30 minutes after extubation(T2). We have defined H0, H1 and H2, the maximum course of the vocal cords measured respectively at T0, T1 and T2

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients proposed for elective surgery under general anesthesia with Tracheal intubation other than ENT surgery, ages 18 to 70 years, consenting, classified ASA class I, II, or III with no history of difficult intubation and/or ventilation,

You may qualify if:

• patients proposed for elective surgery under general anesthesia with Tracheal intubation other than ENT surgery

You may not qualify if:

• Patients whose airway management was ensured by supraglottic device
• Patients who have experienced an intraoperative incident requiring them to be kept intubated after surgery
• ENT surgery
• non consenting patients

Sponsors & Collaborators

• General Administration of Military Health, Tunisia: lead

Study Sites (1)

Elaskri Haythem

Tunis, 1008, Tunisia

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 28, 2024
• Study Start: December 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

TU (1)