Clinical trial

Predicting Post Extubation Stridor in Patients With Intermaxillary Fixation

Name

Post Extubation Stridor

Description

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)

Trial arms

Trial start

2023-05-03

Estimated PCD

2025-02-25

Trial end

2025-06-30

Status

Recruiting

Treatment

budesonide

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

Arms:

Budesonide (B) group

normal saline

5 ml normal saline will be nebulized preoperatively

Arms:

control (C) group

Size

Primary endpoint

Laryngeal air column width ratio

immediately before extubation

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly allocated into two equal groups via opaque coded envelopes', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The preoperative aerosolized drug will be applied by an anesthetist who is not involved in further patient care', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 62, 'type': 'ESTIMATED'}}

Updated at

2024-02-06

1 organization

1 product

1 drug

2 indications

Organization

Product

Indication

Indication

Drug