Comparison of Remifentanil with a Combination of Remimazolam and Dexmedetomidine for Awake Tracheal Intubation

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · Aug 30, 2024

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ClinConnect Summary

This clinical trial is studying two different methods of sedation for patients who need to undergo a special procedure called awake fiberoptic intubation. This is a technique used to help patients breathe when they have a difficult airway. The trial is comparing the use of a single sedative called remifentanil to a combination of remifentanil with another sedative called dexmedetomidine. The goal is to see which method is safer and more effective at keeping patients comfortable and calm during the procedure.

To participate in this study, patients should be between 18 and 65 years old, in good general health (classified as ASA I-III), and have a body mass index (BMI) under 30. Patients who have certain medical conditions, allergies to specific medications, or severe respiratory or heart issues may not be eligible. Those who join the study can expect to receive sedation during their intubation and will be closely monitored by medical staff. This trial is currently recruiting participants, so if you or someone you know might be interested, it could be a good opportunity to contribute to medical research.

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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