Comparison of Efficacy and Safety Between Ciprofol and Remimazolam During Fiberoptic Bronchoscopy

University of Science and Technology of China (USTC)

Status: Not yet enrolling

Conditions: Fiberoptic Bronchoscopy

Treatments: Drug: Remimazolam; Drug: Ciprofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06531915

Fiberoptic bronchoscopy

Details and patient eligibility

About

Both ciprofol and remimazolam have been found to be potential alternatives to propofol (a commonly used anesthesia) during fiberoptic bronchoscopy, while the efficacy and safety between ciprofol and remimazolam have not been reported. This study aims to compare the efficacy and safety between ciprofol and remimazolam in patients undergoing fiberoptic bronchoscopy.

Enrollment: 190 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. male or female patients with age ≥ 18 years old;
2. scheduled to undergo bronchoscopy under laryngeal mask airway;
3. with American Society of Anesthesiologists (ASA) physical status classes II to Ⅲ; and
4. volunteering to participate in this study and signing an informed consent form.

Exclusion criteria

1. with contraindications to deep sedation/general anesthesia or with a history of sedation/anesthesia accidents;
2. allergic to eggs, bean products, or experimental drugs (ciprofol, sufentanil, or remimazolam);
3. difficult airway;
4. with bradycardia or other serious cardiovascular diseases;
5. with severe damages or diseases in important organs such as the lungs, brain, liver, or kidneys;
6. using sedatives or antidepressants for a long time;
7. pregnant or lactating women; and (8) unable to communicate or cooperate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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190 participants in 2 patient groups

Ciprofol group

Experimental group

Treatment:

Drug: Ciprofol

Remimazolam group

Active Comparator group

Treatment:

Drug: Remimazolam