Fiberoptic Bronchoscopy
Conditions
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.
Interventions
DRUGCiprofol
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).
DRUGRemimazolam
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).
Sponsors
Anhui Provincial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of fiberoptic bronchoscopy | 24 hours after fiberoptic bronchoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery time | 24 hours after fiberoptic bronchoscopy | — |
| Stay time in PACU | 24 hours after fiberoptic bronchoscopy | — |
| Induction time | 24 hours after fiberoptic bronchoscopy | — |
| Procedure time | 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 | — |
| Awake time | 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 | — |
| SBP | 6 minutes after fiberoptic bronchoscopy | — |
| Diastolic blood pressure | 6 minutes after fiberoptic bronchoscopy | — |
| SpO2 | 6 minutes after fiberoptic bronchoscopy | — |
| Doses of using rescue sedative drug | 24 hours after fiberoptic bronchoscopy | — |
Outcome results
None listed