Difficult airway
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18~68 years old, gender is not limited; 2. Body mass index (BMI) 18-32 kg/m²; 3. American Society of Anaesthesiologists (ASA) class II or III; 4. The preoperative assessment meets the diagnostic criteria of difficult airway management in the Expert Consensus on Difficult Airway Management (2023 Edition), and any one of the following items is satisfied: (1) mouth opening <3 cm; (2) nail-chin spacing <6.5 cm; (3) Mallampati class ? or ?; (4) cervical spine mobility limitation (neck flexion or extension angle <30°); and (5) clear history of difficult intubation in the past; 5. Elective surgery under general anaesthesia with fibreoptic bronchoscopy-guided awake transnasal tracheal intubation is required; 6. signed informed consent by the patient or his/her legal representative.
Exclusion criteria
Exclusion criteria: 1. hypersensitivity to oxybutynin, sufentanil, dexmedetomidine or other drugs used in the trial (e.g. lidocaine); 2. Presence of coagulation disorders (prothrombin time, activated partial thromboplastin time exceeding 1.5 times the normal range); 3. Nasal anatomical deformity, stenosis or obstruction, which makes intubation through the nose impossible upon assessment; 4. Suffering from mental illness or cognitive dysfunction, unable to co-operate with the pre-operative assessment and intra-operative operation; 5. Combined serious cardiovascular disease (e.g. heart failure, serious arrhythmia, uncontrolled hypertension (systolic blood pressure >= 160mmHg or diastolic blood pressure >= 100mmHg)); 6. Preoperative respiratory insufficiency (SpO2 <95% at rest); 7. Pregnant or lactating women; 8. Participation in other clinical trials within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of hypoxemia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of coughing fits;Ramsay Sedation Scale;Respiratory indicators; | — |
Countries
China
Contacts
Gansu Provincial Hospital