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

Comparison of Efficacy and Safety Between Ciprofol and Remimazolam During Fiberoptic Bronchoscopy: a Study Protocol for a Single-center, Double-blind, Randomized Controlled Trial

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 Overview

• Status: Not yet recruiting
• Conditions: Fiberoptic Bronchoscopy
• Intervention / Treatment: Drug: Ciprofol; Drug: Remimazolam

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ciprofol group	Drug: 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).
Active Comparator: Remimazolam group	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The success rate of fiberoptic bronchoscopy	24 hours after fiberoptic bronchoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction time		24 hours after fiberoptic bronchoscopy
Procedure time		24 hours after fiberoptic bronchoscopy
Awake time		24 hours after fiberoptic bronchoscopy
Recovery time		24 hours after fiberoptic bronchoscopy
Stay time in PACU		24 hours after fiberoptic bronchoscopy
Supplemental times of experimental drugs (ciprofol or remimazolam)		24 hours after fiberoptic bronchoscopy
Doses of experimental drugs (ciprofol or remimazolam)		24 hours after fiberoptic bronchoscopy
Times of using rescue sedative drug		24 hours after fiberoptic bronchoscopy
Doses of using rescue sedative drug		24 hours after fiberoptic bronchoscopy
Incidence of adverse events		24 hours after fiberoptic bronchoscopy
Patients' satisfaction	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.	24 hours after fiberoptic bronchoscopy
Heart rate		6 minutes after fiberoptic bronchoscopy
SBP		6 minutes after fiberoptic bronchoscopy
Diastolic blood pressure		6 minutes after fiberoptic bronchoscopy
SpO2		6 minutes after fiberoptic bronchoscopy

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Fiberoptic bronchoscopy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No