Clinical trial NCT06283329: Residual Vocal Cords Curarization Correlation Between Clinical and Ultrasound Endpoints
Official title: Residual Vocal Cords Curarization Correlation Between Clinical and Ultrasound Endpoints
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Residual Curarization
Keywords: residual curarization
airway access
echography
Lead sponsor: General Administration of Military Health, Tunisia
Sponsor class: NETWORK
First posted: 2024-02-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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,

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Echographic mobility of vocal cords at different times in post extubation
timeFrame: before induction (T0), immediately after extubation (T1) and 30 minutes after extubation (T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Elaskri Haythem
Study officials:
References: