Predicting Post Extubation Stridor After Maxillomandibular Fixation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMansoura University
About this trial
Endotracheal intubation can induce laryngotracheal injury which results in narrowing of the airway due to edema of the glottis. This can increase the risk of development of post-extubation stridor (PES)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (>18 years)
American Society of Anesthesiologists status I and II
undergoing elective maxillomandibular fixation surgeries under general anesthesia with nasal endotracheal intubation
Disqualifiers
patients' refusal
pregnant females
patients with body mass index <18.5 or ≥ 35 kg/m2
risk of aspiration
Trial design
Design model
Parallel
Treatments tested in this trial
budesonide
Drug2 ml nebulized budesonide (containing 1 mg) diluted in 3 ml of normal saline will be nebulized preoperatively
normal saline
Drug5 ml normal saline will be nebulized preoperatively
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: control (C) groupPlacebo comparator 1 intervention
Group B: Budesonide (B) groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Laryngeal air column width ratio
%
Time frame
immediately before extubationSecondary outcomes
1
The duration of nasal endotracheal intubation
min
Time frame
Procedure (from nasal endotracheal intubation till extubation)2
endotracheal tube insertion depth
cm
Time frame
immediately after intubation3
The incidence of epistasis occurrence during nasotracheal intubation
4-point verbal descriptor scale (0=no symptoms, 1=mild, 2=moderate, 3=severe)
Time frame
immediately after intubation4
Expiratory tidal volume immediate after intubation with the cuff inflated
ml
Time frame
immediately after intubationOther outcomes
1
Expiratory tidal volume immediate after intubation with the cuff deflated
ml
Time frame
immediately after intubation2
Expiratory tidal volume immediate before extubation with the cuff inflated
ml
Time frame
immediately before extubation3
Expiratory tidal volume immediate before extubation with the cuff deflated
ml
Time frame
immediately before extubation4
cuff leak volume
ml
Time frame
immediate after intubation and immediate before extubationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov