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Clinical Trials/NCT06531915
NCT06531915
Not yet recruiting
Not Applicable

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

Anhui Provincial Hospital0 sites190 target enrollmentStarted: December 1, 2024Last updated:
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ConditionsFiberoptic Bronchoscopy
InterventionsCiprofolRemimazolam

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Anhui Provincial Hospital
Enrollment
190
Primary Endpoint
The success rate of fiberoptic bronchoscopy
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

Ciprofol group

Experimental

Intervention: Ciprofol (Drug)

Remimazolam group

Active Comparator

Intervention: Remimazolam (Drug)

Outcomes

Primary Outcomes

The success rate of fiberoptic bronchoscopy

Time Frame: 24 hours after fiberoptic bronchoscopy

Secondary Outcomes

  • 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)
  • 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)

Investigators

Sponsor
Anhui Provincial Hospital
Sponsor Class
Other Gov
Responsible Party
Sponsor

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