Predicting Post Extubation Stridor After Maxillomandibular Fixation

NCT05839756 | Recruiting

• 1 other identifier: Post Extubation Stridor
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Stridor; Larynx Edema

Outcome Measures

Primary Outcomes (1)

• Laryngeal air column width ratio

  %

  immediately before extubation

Secondary Outcomes (4)

• The duration of nasal endotracheal intubation

  Procedure (from nasal endotracheal intubation till extubation)

• endotracheal tube insertion depth

  immediately after intubation

• The incidence of epistasis occurrence during nasotracheal intubation

  immediately after intubation

• Expiratory tidal volume immediate after intubation with the cuff inflated

  immediately after intubation

Other Outcomes (9)

• Expiratory tidal volume immediate after intubation with the cuff deflated

  immediately after intubation

• Expiratory tidal volume immediate before extubation with the cuff inflated

  immediately before extubation

• Expiratory tidal volume immediate before extubation with the cuff deflated

  immediately before extubation

Study Arms (2)

control (C) group

PLACEBO COMPARATOR

normal saline will be nebulized

Drug: normal saline

Budesonide (B) group

ACTIVE COMPARATOR

budesonide will be nebulized

Drug: budesonide

Interventions

budesonide DRUG

2 ml nebulized budesonide (containing 1 mg) diluted in 3 ml of normal saline will be nebulized preoperatively

Budesonide (B) group

normal saline DRUG

5 ml normal saline will be nebulized preoperatively

control (C) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>18 years)
• American Society of Anesthesiologists status I and II
• undergoing elective maxillomandibular fixation surgeries under general anesthesia with nasal endotracheal intubation

You may not qualify if:

• patients' refusal
• pregnant females
• patients with body mass index \<18.5 or ≥ 35 kg/m2
• risk of aspiration
• cardiorespiratory disorder
• neuromuscular disease
• uncontrolled diabetes mellitus
• gastrointestinal bleeding
• on chronic steroid therapy
• intubated patients or were intubated or had upper airway infection within 1 week prior to surgery
• history of any pathology, radiotherapy or surgery in the neck
• had difficult laryngeal US plane (as neck wound)

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Maha Ahmed AboZeid

Al Mansurah, Mansoura, 35511, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Sounds; Laryngeal Edema

Interventions

Budesonide; Saline Solution

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Maha A AboZeid, MD

CONTACT

02-01019216192; mahazed@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The preoperative aerosolized drug will be applied by an anesthetist who is not involved in further patient care
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Surgical Intensive Care

Model Details: Patients will be randomly allocated into two equal groups via opaque coded envelopes

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 3, 2023
• Study Start: May 3, 2023
• Primary Completion (Estimated): February 25, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

EG (1)