RecruitingNot ApplicableNCT06581731

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

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


Sponsor

Nanjing First Hospital, Nanjing Medical University

Enrollment

60 participants

Start Date

Sep 19, 2024

Study Type

INTERVENTIONAL

Conditions

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 patient comfort and tolerance, reduce anxiety, and eliminate harmful effects on systemic hemodynamics.The objective of this study is to compare the safety and efficacy of remifentanil alone versus a combination of dexmedetomidine and remifentanil for sedation during conscious tracheal intubation.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

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

Exclusion Criteria9

  • 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

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Interventions

DRUGremimazolam combined with remifentanil

Patients in this group will receive a bolus of remimazolam 5 mg intravenously, and then a dose of 0.1 μg/kg/min remifentanil and 0.5 mg/kg/h remimazolam via separate syringe pumps.

DRUGdexmedetomidine combined with remifentanil

Patients in this group will receive a loading dose of dexmedetomidine 1 μg/kg over 10 minutes intravenously, and then a dose of 0.1 μg/kg/min remifentanil and 0.5 μg/kg/h dexmedetomidine via separate syringe pumps.


Locations(1)

Nanjing First Hospital

Nanjing, Jiangsu, China

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NCT06581731


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