Status:
RECRUITING
Comparison of Remifentanil with a Combination of Remimazolam and Dexmedetomidine for Awake Tracheal Intubation
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Difficult or Failed Intubation
Sedative Adverse Reaction
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Awake fiberoptic intubation (AFOI) requires airway surface anesthesia to inhibit pharyngeal reflex, glottis closure reflex, and cough reflex. Additionally, the use of sedative drugs can enhance patien...
Detailed Description
Awake fiberoptic intubation (AFOI) is regarded as the gold standard for managing anticipated difficult airways due to its high success rate and low risk. However, awake intubation can induce significa...
Eligibility Criteria
Inclusion
- Patients undergoing general anesthesia who require awake nasal tracheal intubation.
- Age 18-65 years old
- ASA classifications of I-III
- BMI\<30kg/m2
Exclusion
- Patients allergic to propofol, midazolam, dexmedetomidine, remifentanil.
- Second- or third-degree atrioventricular block, rate \<50 beats/min, systolic blood pressure \<90 mmHg
- Acute exacerbation of respiratory diseases such as asthma, bronchitis, and chronic obstructive pulmonary disease (COPD)
- Patients with acute arrhythmias and severe heart disease (congenital, valvular diseases)
- Patients with severe liver or kidney dysfunction requiring replacement therapy
- Patients with severe mental disorders requiring medication for symptom control and experiencing communication barriers
- Patients with moderate to severe anemia, coagulation disorders, and hematologic diseases
- Patients with basal skull fractures, facial fractures, significantly deviated nasal septum, or nasal cavity diseases causing severe nasal congestion
- patients on long-term opioids or sedative medication
Key Trial Info
Start Date :
September 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06581731
Start Date
September 19 2024
End Date
October 20 2025
Last Update
September 23 2024
Active Locations (1)
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1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210000