Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283329
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2024-02-15
Brief Title:
Residual Vocal Cords Curarization Correlation Between Clinical and Ultrasound Endpoints
Sponsor:
General Administration of Military Health Tunisia
Organization:
General Administration of Military Health Tunisia
Study Overview
Official Title:
Residual Vocal Cords Curarization Correlation Between Clinical and Ultrasound Endpoints
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 HAt1H1H0 HAt2H2H0 The investigators conducted a single then multi-variate analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None