RecruitingNot Applicable

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

China60 participantsStarted 2024-09-19

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. 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

What they're measuring

intubation scores

Timeframe: preoperative

intubation comfort scores

Timeframe: preoperative

Trial details

NCT IDNCT06581731

SponsorNanjing First Hospital, Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-10

Contact for this trial

Jing Hu, MD

15366110201 hujingmz@@163.com

View on ClinicalTrials.gov More Difficult or Failed Intubation trials