Fiberoptic BronchoscopyNCT06531915
Comparison of Efficacy and Safety Between Ciprofol and Remimazolam During Fiberoptic Bronchoscopy
A study testing Ciprofol and Remimazolam in people with Fiberoptic Bronchoscopy, run by Anhui Provincial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fiberoptic Bronchoscopy
- What is being tested?
- Ciprofol and Remimazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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
- Being tested
- Ciprofol, Remimazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofolDrug
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).
RemimazolamDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Ciprofol group | Experimental | Not described Receives: Drug: Ciprofol |
| Remimazolam group | Active comparator | Not described Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of fiberoptic bronchoscopy
Measured: 24 hours after fiberoptic bronchoscopy
Secondary outcomes (15)
Induction time
Measured: 24 hours after fiberoptic bronchoscopy
Procedure time
Measured: 24 hours after fiberoptic bronchoscopy
Awake time
Measured: 24 hours after fiberoptic bronchoscopy
Recovery time
Measured: 24 hours after fiberoptic bronchoscopy
Stay time in PACU
Measured: 24 hours after fiberoptic bronchoscopy
Supplemental times of experimental drugs (ciprofol or remimazolam)
Measured: 24 hours after fiberoptic bronchoscopy
Doses of experimental drugs (ciprofol or remimazolam)
Measured: 24 hours after fiberoptic bronchoscopy
Times of using rescue sedative drug
Measured: 24 hours after fiberoptic bronchoscopy
Doses of using rescue sedative drug
Measured: 24 hours after fiberoptic bronchoscopy
Incidence of adverse events
Measured: 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.
Measured: 24 hours after fiberoptic bronchoscopy
Heart rate
Measured: 6 minutes after fiberoptic bronchoscopy
SBP
Measured: 6 minutes after fiberoptic bronchoscopy
Diastolic blood pressure
Measured: 6 minutes after fiberoptic bronchoscopy
SpO2
Measured: 6 minutes after fiberoptic bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fiberoptic BronchoscopyStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531915
- Sponsor's protocol ID
- Fiberoptic bronchoscopy
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06531915
- Acronym / sponsor ID
- Fiberoptic bronchoscopy
- Conditions
- Fiberoptic Bronchoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofol group | Experimental | Drug: Ciprofol |
| Remimazolam group | Active comparator | Drug: Remimazolam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprofolParticipants 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). | Drug | Ciprofol group |
| RemimazolamParticipants 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). | Drug | Remimazolam group |
Primary outcome
The success rate of fiberoptic bronchoscopy
Time frame: 24 hours after fiberoptic bronchoscopy
15 secondary outcomes
Induction time
Time frame: 24 hours after fiberoptic bronchoscopy
Procedure time
Time frame: 24 hours after fiberoptic bronchoscopy
Awake time
Time frame: 24 hours after fiberoptic bronchoscopy
Recovery time
Time frame: 24 hours after fiberoptic bronchoscopy
Stay time in PACU
Time frame: 24 hours after fiberoptic bronchoscopy
Supplemental times of experimental drugs (ciprofol or remimazolam)
Time frame: 24 hours after fiberoptic bronchoscopy
Doses of experimental drugs (ciprofol or remimazolam)
Time frame: 24 hours after fiberoptic bronchoscopy
Times of using rescue sedative drug
Time frame: 24 hours after fiberoptic bronchoscopy
Doses of using rescue sedative drug
Time frame: 24 hours after fiberoptic bronchoscopy
Incidence of adverse events
Time frame: 24 hours after fiberoptic bronchoscopy
Patients' satisfaction
Time frame: 24 hours after fiberoptic bronchoscopy
Heart rate
Time frame: 6 minutes after fiberoptic bronchoscopy
SBP
Time frame: 6 minutes after fiberoptic bronchoscopy
Diastolic blood pressure
Time frame: 6 minutes after fiberoptic bronchoscopy
SpO2
Time frame: 6 minutes after fiberoptic bronchoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ciprofol and Remimazolam in people with Fiberoptic Bronchoscopy, run by Anhui Provincial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of fiberoptic bronchoscopy (time frame: 24 hours after fiberoptic bronchoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.