Comparing two sedation methods for awake tracheal intubation

Comparison of the Safety and Effectiveness of Remifentanil with a Combination of Remimazolam and Dexmedetomidine for Awake Fibreoptic Nasotracheal Intubation

This study is testing whether using remifentanil alone or a mix of dexmedetomidine and remifentanil can make awake tracheal intubation more comfortable and safer for patients with difficult airways.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06581731 on ClinicalTrials.gov

What this trial studies

This study aims to compare the safety and efficacy of remifentanil alone versus a combination of dexmedetomidine and remifentanil for sedation during awake fiberoptic intubation (AFOI). AFOI is the preferred method for managing anticipated difficult airways, but it can induce significant stress responses in patients. The study will evaluate how well these sedation methods help manage patient comfort, anxiety, and hemodynamic stability while minimizing complications. Participants will be monitored for their response to the sedation during the intubation process.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 who require awake nasal tracheal intubation and have an ASA classification of I-III.

Not a fit: Patients with severe respiratory diseases, significant heart conditions, or those with allergies to the study medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve sedation techniques during awake intubation, enhancing patient comfort and safety.

How similar studies have performed: Previous studies have shown varying success with sedation techniques in AFOI, but this specific combination approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients undergoing general anesthesia who require awake nasal tracheal intubation.
2. Age 18-65 years old
3. ASA classifications of I-III
4. BMI\<30kg/m2

Exclusion Criteria:

1. Patients allergic to propofol, midazolam, dexmedetomidine, remifentanil.
2. Second- or third-degree atrioventricular block, rate \<50 beats/min, systolic blood pressure \<90 mmHg
3. Acute exacerbation of respiratory diseases such as asthma, bronchitis, and chronic obstructive pulmonary disease (COPD)
4. Patients with acute arrhythmias and severe heart disease (congenital, valvular diseases)
5. Patients with severe liver or kidney dysfunction requiring replacement therapy
6. Patients with severe mental disorders requiring medication for symptom control and experiencing communication barriers
7. Patients with moderate to severe anemia, coagulation disorders, and hematologic diseases
8. Patients with basal skull fractures, facial fractures, significantly deviated nasal septum, or nasal cavity diseases causing severe nasal congestion
9. patients on long-term opioids or sedative medication

Where this trial is running

Nanjing, Jiangsu

• Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Jing Hu, MD

Conditions Difficult or Failed Intubation; Sedative Adverse Reaction; AFOI; Dexmedetomidine; Rimazazolam; Remifentanil