Clinical trial NCT06531915: Comparison of Efficacy and Safety Between Ciprofol and Remimazolam During Fiberoptic Bronchoscopy
Official title: Comparison of Efficacy and Safety Between Ciprofol and Remimazolam During Fiberoptic Bronchoscopy: a Study Protocol for a Single-center, Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fiberoptic Bronchoscopy
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-01
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The success rate of fiberoptic bronchoscopy
timeFrame: 24 hours after fiberoptic bronchoscopy
Secondary outcomes:
measure: Induction time
timeFrame: 24 hours after fiberoptic bronchoscopy
measure: Procedure time
timeFrame: 24 hours after fiberoptic bronchoscopy
measure: Awake time
timeFrame: 24 hours after fiberoptic bronchoscopy
measure: Recovery time
timeFrame: 24 hours after fiberoptic bronchoscopy
measure: Stay time in PACU
timeFrame: 24 hours after fiberoptic bronchoscopy
measure: Supplemental times of experimental drugs (ciprofol or remimazolam)
timeFrame: 24 hours after fiberoptic bronchoscopy
measure: Doses of experimental drugs (ciprofol or remimazolam)
timeFrame: 24 hours after fiberoptic bronchoscopy
measure: Times of using rescue sedative drug
timeFrame: 24 hours after fiberoptic bronchoscopy
measure: Doses of using rescue sedative drug
timeFrame: 24 hours after fiberoptic bronchoscopy
measure: Incidence of adverse events
timeFrame: 24 hours after fiberoptic bronchoscopy
measure: Patients' satisfaction
timeFrame: 24 hours after fiberoptic bronchoscopy
measure: Heart rate
timeFrame: 6 minutes after fiberoptic bronchoscopy
measure: SBP
timeFrame: 6 minutes after fiberoptic bronchoscopy
measure: Diastolic blood pressure
timeFrame: 6 minutes after fiberoptic bronchoscopy
measure: SpO2
timeFrame: 6 minutes after fiberoptic bronchoscopy
Other outcomes:
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