Combining Remimazolam and Afentanil for Awake Intubation

Compatible Dose Study and Effect Observation of Remimazolam Besylate Combined With Afentanil for Awake Endotracheal Intubation

This study is testing if a combination of two medications, remimazolam and alfentanil, can make awake intubation safer and more effective for patients with difficult airways.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06026566 on ClinicalTrials.gov

What this trial studies

This study investigates the pharmacokinetics of remimazolam besylate when combined with alfentanil during awake endotracheal intubation (ATI). It aims to determine the optimal dosages of these medications to enhance the safety and effectiveness of ATI, which is crucial for patients with difficult airways. The study will provide clinical guidance on the use of these drugs in ATI procedures, ensuring better management of airway control while patients are awake. By focusing on a method that minimizes risks associated with anesthesia induction, the research seeks to improve patient outcomes in airway management.

Who should consider this trial

Good fit: Ideal candidates for this study are patients without predictable difficult airways and with a Mallampati grade of I-II.

Not a fit: Patients with head and neck lesions, significant respiratory diseases, or known allergies to the study medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the safety and efficacy of awake intubation procedures for patients with difficult airways.

How similar studies have performed: While the concept of awake intubation is established, the specific combination of remimazolam and alfentanil in this context is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. no predictable difficult airway, Mallampati grade Ⅰ-II;
2. deviation from ideal body weight ≤25%;

   \[Ideal weight (kg) = height (cm) -100 (male) or 105 (female)\]
3. American Society of Anesthesiologists grade Ⅰ-II;
4. Informed consent: voluntarily participate in the trial and sign the informed consent.

Exclusion Criteria:

1. patients with head and neck lesions (including malignant tumors, previous surgery or radiotherapy), limited mouth opening, limited neck extension, obstructive sleep apnea, morbid obesity, and progressive airway injury;
2. Relative contraindications: patients with respiratory diseases, allergy to local anesthetics, airway bleeding, and non-cooperation;
3. patients known to be allergic to remimazolam besylate or benzodiazepines;
4. patients with known allergy to alfentanil or opioids;
5. body weight exceeding ±25% of ideal body weight;
6. patients with coagulation dysfunction, endocrine diseases or other hemodynamic conditions;
7. patients with a history of drug or alcohol dependence;
8. Subjects who were deemed unsuitable for the study by the investigators.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Qiaoqiao Xu — Tongji Hospital
• Study coordinator: Qiaoqiao Xu

Conditions Remimazolam; Awake Endotracheal Intubation