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

Not Applicable

Not yet recruiting

• Conditions: Fiberoptic Bronchoscopy
• Interventions: Drug: Ciprofol; Drug: Remimazolam

• Registration Number: NCT06531915
• Lead Sponsor: Anhui Provincial Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-07-30
• Last Update Submitted: 2024-07-30
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Study Start: 2024-12-01
• Primary Completion: 2024-12-30
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 190

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ciprofol group	Ciprofol	-
Remimazolam group	Remimazolam	-

Primary Outcome Measures

Name	Time	Method
The success rate of fiberoptic bronchoscopy	24 hours after fiberoptic bronchoscopy

Secondary Outcome Measures

Name	Time	Method
Recovery time	24 hours after fiberoptic bronchoscopy
Doses of experimental drugs (ciprofol or remimazolam)	24 hours after fiberoptic bronchoscopy
Stay time in PACU	24 hours after fiberoptic bronchoscopy
Diastolic blood pressure	6 minutes after fiberoptic bronchoscopy
SpO2	6 minutes after fiberoptic bronchoscopy
Procedure time	24 hours after fiberoptic bronchoscopy
Awake time	24 hours after fiberoptic bronchoscopy
Times of using rescue sedative drug	24 hours after fiberoptic bronchoscopy
Incidence of adverse events	24 hours after fiberoptic bronchoscopy
Patients' satisfaction	24 hours after fiberoptic bronchoscopy	Patients' satisfaction is assessed using the Satisfaction Scale reported by Luo et al. The Satisfaction Scale ranges from 0 to 10 points and contains five items. The higher score indicates better satisfaction.
Heart rate	6 minutes after fiberoptic bronchoscopy
Induction time	24 hours after fiberoptic bronchoscopy
Supplemental times of experimental drugs (ciprofol or remimazolam)	24 hours after fiberoptic bronchoscopy
Doses of using rescue sedative drug	24 hours after fiberoptic bronchoscopy
SBP	6 minutes after fiberoptic bronchoscopy