UnknownNot Applicable

Compatible Effect of Remimazolam Besylate Combined With Afentanil for ATI

China180 participantsStarted 2023-04-01

Plain-language 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 awake endotracheal intubation.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. no predictable difficult airway, Mallampati grade Ⅰ-II;
✓. deviation from ideal body weight ≤25%;
✓. American Society of Anesthesiologists grade Ⅰ-II;
✓. Informed consent: voluntarily participate in the trial and sign the informed consent.

Exclusion criteria

✕. 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.

What they're measuring

Respiratory Rate

Timeframe: During surgery

Tidal volume

Timeframe: During surgery

Deep breathing

Timeframe: During surgery

Airway obstruction

Timeframe: During surgery

Oxygen saturation decreased

Timeframe: During surgery

Trial details

NCT IDNCT06026566

SponsorTongji Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-31

Contact for this trial

Qiaoqiao Xu

+8618771006963 qiaoqiaoxu@aliyun.com

View on ClinicalTrials.gov More Remimazolam trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. no predictable difficult airway, Mallampati grade Ⅰ-II;
✓. deviation from ideal body weight ≤25%;
✓. American Society of Anesthesiologists grade Ⅰ-II;
✓. Informed consent: voluntarily participate in the trial and sign the informed consent.

Exclusion criteria

✕. 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.