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

NCT ID: NCT06531915

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-03-31

Brief Summary

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.

Conditions

Fiberoptic Bronchoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ciprofol group

Group Type: EXPERIMENTAL

Ciprofol

Intervention Type: DRUG

Participants in the ciprofol group will be intravenously injected with 0.4 mg/kg of ciprofol (batch number H20200013, Haisike Pharmaceutical Co., Ltd., Liaoning, China) and sufentanil (0.2 μg/kg).

Remimazolam group

Group Type: ACTIVE_COMPARATOR

Remimazolam

Intervention Type: DRUG

Participants in the remimazolam group will be intravenously injected with 0.1 mg/kg of remimazolam besylate (batch number HR7056, Hengrui Pharmaceutical Co., Ltd., Jiangsu, China) and sufentanil (0.2 μg/kg).

Interventions

Ciprofol

Participants in the ciprofol group will be intravenously injected with 0.4 mg/kg of ciprofol (batch number H20200013, Haisike Pharmaceutical Co., Ltd., Liaoning, China) and sufentanil (0.2 μg/kg).

Intervention Type: DRUG

Remimazolam

Participants in the remimazolam group will be intravenously injected with 0.1 mg/kg of remimazolam besylate (batch number HR7056, Hengrui Pharmaceutical Co., Ltd., Jiangsu, China) and sufentanil (0.2 μg/kg).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Fiberoptic bronchoscopy

Identifier Type: -

Identifier Source: org_study_id