Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06581731

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

Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2024-09-23

60

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing general anesthesia who require awake nasal tracheal intubation
  • Age 18-65 years old
  • ASA classifications of I-III
  • Body mass index (BMI) less than 30 kg/m2
Not Eligible

You will not qualify if you...

  • Allergy to propofol, midazolam, dexmedetomidine, or remifentanil
  • Second- or third-degree atrioventricular block, heart rate below 50 beats per minute, or systolic blood pressure below 90 mmHg
  • Acute worsening of respiratory diseases such as asthma, bronchitis, or COPD
  • Acute arrhythmias or severe heart diseases including congenital or valvular diseases
  • Severe liver or kidney dysfunction requiring replacement therapy
  • Severe mental disorders needing medication and causing communication barriers
  • Moderate to severe anemia, blood clotting disorders, or blood diseases
  • Basal skull fractures, facial fractures, severely deviated nasal septum, or nasal diseases causing severe congestion
  • Long-term use of opioids or sedative medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nanjing First Hospital

Nanjing, Jiangsu, China, 210000

Actively Recruiting

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Research Team

J

Jing Hu, MD

CONTACT

L

Lihai Chen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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