Residual Vocal Cords Curarization Correlation Between Clinical and Ultrasound Endpoints

Residual Curarization Clinical Trial

Official title:

Residual Vocal Cords Curarization Correlation Between Clinical and Ultrasound Endpoints

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06283329
• Other study ID #: echographic VC curarization
• Status: Completed
• Start date: December 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: General Administration of Military Health, Tunisia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The investigators conducted an analytical prospective observational and comparative study between March 2022 and May 2022. The investigators included all 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, divided into two groups that differ by neostigmine use: group A: systematic decurarization, group B: extubation through clinical criteria. Ultrasound assessments of the vocal cords were performed at 3 different time points: before induction (T0), after extubation (T1), in SSPI 30 minutes after extubation (T2). The investigators have defined H0, H1 and H2, the maximum amplitudes of the vocal cords measured respectively at T0, T1 and T2. The primary endpoint was the ultrasound judged vocal cord range of motion with a ratio of pre- to post curarization amplitude defining the HA score, calculated using the following formulas: H0-H1, H0-H2, HAt1=H1/H0, HAt2=H2/H0. The investigators conducted a single then multi-variate analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Residual Curarization

Intervention

Diagnostic Test:
• vocal cords echography
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

Locations

Country	Name	City	State
Tunisia	Elaskri Haythem	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
General Administration of Military Health, Tunisia

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)