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Compatible dose study and effect observation of Remimazolam Besylate combined with Afentanil for awake endotracheal intubation

Compatible dose study and effect observation of Remimazolam Besylate combined with Afentanil for awake endotracheal intubation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112426
Enrollment
Unknown
Registered
2025-11-13
Start date
2023-04-20
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Awake endotracheal intubation

Interventions

Remazolam besylate 0.1 mg/kg group:Different concentrations of afentanil (50-110)ng/ml
Remazolam besylate 0.15mg/kg group:Different concentrations of afentanil (40-90)ng/ml
Remazolam besylate 0.2mg/kg group:Different concentrations of afentanil (30-80)ng/ml
Remazolambesylate 0.25mg/kg group:Different concentrations of afentanil (30-80)ng/ml
Remazolam besylate 0.3mg/kg group:Different concentrations of afentanil (20-70)ng/ml
Remazolam besylate 0.35mg/kg group:Different concentrations of afentanil (20-70)ng/ml

Sponsors

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. There was no predictable difficult airway, Mallampati grades ? to II; 2. Deviation from the ideal weight <=25%; 3. Aged 18-64 years; 4. American Society of Anesthesiologists ASA Class I-II; 5. Informed consent, voluntary participation in the experiment, and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with head and neck lesions (including malignancies, prior surgery or radiotherapy), limited mouth opening, limited neck extension, obstructive sleep apnea, moropathic obesity, and progressive airway injury; 2. Relative contraindications: patients with respiratory diseases, allergies to local anesthetics, airway bleeding, and uncooperation; 3. Patients with a known allergy to remazolam besylate or benzodiazepines; 4. Patients with a known allergy to afentanil or opioids; 5. The body weight exceeds the ideal body weight by ±25%; 6. Patients with abnormal coagulation function, endocrine diseases or other effects on hemodynamic status; 7. Patients with a history of drug and alcohol dependence; 8. Patients considered unsuitable for this study by the researcher.

Design outcomes

Primary

MeasureTime frame
Assessment of respiratory depression;

Secondary

MeasureTime frame
Airway condition;Tracheal Intubation response;Body movement in tracheal intubation;RASS score during tracheal intubation;Hemodynamic indicators during tracheal intubation;Satisfaction with the anesthesia plan;

Countries

China

Contacts

Public ContactQiaoqiao Xu

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University

qiaoqiaoxu@aliyun.com+86 187 7100 6963

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026