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

NCT06531915 | Not Yet Recruiting

• 1 other identifier: Fiberoptic bronchoscopy
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• The success rate of fiberoptic bronchoscopy

  24 hours after fiberoptic bronchoscopy

Secondary Outcomes (15)

• 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

Study Arms (2)

Ciprofol group

EXPERIMENTAL

Drug: Ciprofol

Remimazolam group

ACTIVE COMPARATOR

Drug: Remimazolam

Interventions

Ciprofol 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).

Ciprofol group

Remimazolam 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).

Remimazolam group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

MeSH Terms

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; remimazolam

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: August 1, 2024
• Study Start: December 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: March 31, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share