Status:
UNKNOWN
Compatible Effect of Remimazolam Besylate Combined With Afentanil for ATI
Lead Sponsor:
Tongji Hospital
Conditions:
Remimazolam
Awake Endotracheal Intubation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
1. To study the pharmacokinetics between remimazolam besylate and alfentanil; 2. To determine the optimal dosage of the two drugs in awake endotracheal intubation; 3. To provide clinical guidance for ...
Detailed Description
Tracheal intubation is the most effective and reliable method to establish artificial airway, which provides the best conditions for relieving airway obstruction, ensuring airway patency, removing res...
Eligibility Criteria
Inclusion
- no predictable difficult airway, Mallampati grade Ⅰ-II;
- deviation from ideal body weight ≤25%;
- \[Ideal weight (kg) = height (cm) -100 (male) or 105 (female)\]
- American Society of Anesthesiologists grade Ⅰ-II;
- Informed consent: voluntarily participate in the trial and sign the informed consent.
Exclusion
- 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;
- Relative contraindications: patients with respiratory diseases, allergy to local anesthetics, airway bleeding, and non-cooperation;
- patients known to be allergic to remimazolam besylate or benzodiazepines;
- patients with known allergy to alfentanil or opioids;
- body weight exceeding ±25% of ideal body weight;
- patients with coagulation dysfunction, endocrine diseases or other hemodynamic conditions;
- patients with a history of drug or alcohol dependence;
- Subjects who were deemed unsuitable for the study by the investigators.
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06026566
Start Date
April 1 2023
End Date
December 31 2025
Last Update
September 7 2023
Active Locations (1)
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1
Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University
Wuhan, Hubei, China, 430030