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

N/AUnknownNCT06531915

Anhui Provincial Hospital190 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

190

Conditions

Fiberoptic Bronchoscopy

Interventions

CiprofolDRUG

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).

RemimazolamDRUG

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.