Residual Vocal Cords Curarization Correlation Between Clinical and Ultrasound Endpoints

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.

Study Overview

• Status: Completed
• Conditions: Residual Curarization
• Intervention / Treatment: Diagnostic test: vocal cords echography

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 1008
    • Elaskri Haythem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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,

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 B; a group of patients extubated through clinical criteria without use of neostigmine	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: General Administration of Military Health, Tunisia

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Estimated): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: echography; residual curarization; airway access
• Other Study ID Numbers: echographic VC curarization

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