Respiratory DiseaseNCT05835713
Total Intravenous Anesthesia for Rigid Bronchoscopy Using Remimazolam
A study testing Remimazolam besylate and Propofol in people with Respiratory Disease and Tracheal Stenosis, run by Samsung Medical Center.
Trial summary
Rigid bronchoscopy usually requires deep general anesthesia, but the duration of the procedure is relatively short. Remimazolam, a recently developed anesthetics, showed faster recovery from anesthesia and stable hemodynamics compared to propofol, the most popular anesthetics. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Respiratory Disease, Tracheal Stenosis, Endobronchial Mass
- What is being tested?
- Remimazolam besylate and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Apr 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who undergoing rigid bronchoscopy under general anesthesia in Samsung Medical Center, Seoul, South Korea
- American Society of Anesthesiologists physical status I, II, III
Who cannot join
- patients who are contraindicated in benzodiazepine (e,g., allergy to the drug or have a history of hypersensitivity reactions)
- drug or alcohol addiction
- neuromuscular disease or mental illness
- metabolic disease
- emergency surgery
- body mass index >30 kg/m2 or <18.5 kg/m2
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- patient's refusal
- patients in shock or coma
- Patients contraindicated to remimazolam such as acute narrow-angle glaucoma, sleep apnea, severe or acute respiratory failure, galactose intolerance, lactase deficiency, glucose-galactose malabsorption, severe hypersensitivity to dextran 40.
About this study
Official title: Total Intravenous Anesthesia for Rigid Bronchoscopy - Remimazolam Versus Propofol: a Prospective Randomized Controlled Trial
Rigid bronchoscopy usually requires deep general anesthesia, but the duration of the procedure is relatively short. Remimazolam, a recently developed anesthetics, showed faster recovery from anesthesia and stable hemodynamics compared to propofol, the most popular anesthetics. However, few studies have investigated the usefulness of remimazolam for rigid bronchoscopy. Therefore, the investigators compared the usefulness of propofol and remimazolam in total intravenous anesthesia for rigid bronchoscopy.
Read the detailed description
Rigid bronchoscopy usually requires deep general anesthesia, but the duration of the procedure is relatively short. Therefore, anesthesiologists need anesthetics that simultaneously provide hemodynamical stability and faster recovery from anesthesia. Remimazolam showed faster recovery from anesthesia and stable hemodynamic profiles compared to propofol, the most popular anesthetics during general anesthesia. However, few studies have investigated the usefulness of remimazolam during rigid bronchoscopy. In this randomized controlled trial, the investigators want to compare the recovery duration from anesthesia after a rigid bronchoscopy procedure between patients undergoing intravenous anesthesia using remimazolam and propofol.
- Conditions
- Respiratory Disease, Tracheal Stenosis, Endobronchial Mass
- Being tested
- Remimazolam besylate, Propofol
- Keywords
- Remimazolam, Rigid bronchoscopy
- Medical subject headings
- Respiration Disorders, Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylateDrug
Also called Byfavo
Remimazolam group is induced general anesthesia using remimazolam besylate injection (0.2mg/kg bolus). General anesthesia is maintained using remimazolam infusion at a rate of 1mg/kg/h and remifentanil infusion at a rate of 0.05-0.15 mcg/kg/min. After recovering spontaneous respiration during emergence, remimazolam group receive flumazenil injection (0.5 mg)
PropofolDrug
Propofol group is induced general anesthesia using propofol injection (2 mg/kg bolus). General anesthesia is maintained using propofol infusion at a rate of 4-8 mg/kg/h and remifentanil infusion at a rate of 0.05-0.15 mcg/kg/min.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam besylate | Experimental | Remimazolam group receive total intravenous anesthesia using remimazolam besylate and remifentanil during rigid bronchoscopy. Remimazolam group receive flumazenil during the emergence from anesthesia. Receives: Drug: Remimazolam besylate |
| Propofol | Active comparator | Propofol group receive total intravenous anesthesia using propofol and remifentanil during rigid bronchoscopy. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of emergence after rigid bronchoscopy
The time interval between the end of anesthetics infusion and the extubation
Measured: From the end of anesthetics infusion to the extubation, an average of 10 minutes
Secondary outcomes (3)
The duration of induction before rigid bronchoscopy
Time interval between the start of anesthetics infusion and loss of responsiveness
Measured: From the start of anesthetics infusion to the loss of responsiveness, an average of 5 minutes
Awareness during general anesthesia
Whether patient experience awareness during general anesthesia. Awareness during general anesthesia will be assessed with the use of a modified Brice questionnaire. 30 minutes after the arrival at a postanesthesia care unit, a study staff who is blind to the allocation of patients will interview the patient.
Measured: From the start of anesthetics infusion to the extubation, an average of 30 minutes
Use of vasoactive medication during rigid bronchoscopy
Whether vasoactive medication is needed to maintain vital signs within 20% of baseline
Measured: From the start of anesthetics infusion to the extubation, an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Why it stopped: Identically designed study had been published before enrollment of first participant. Therefore, this study was not started. The IRB was approved the withdrawn of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Joo Ahn, Samsung Medical Center
- Investigators
- Hyun Joo Ahn, MD, PhD, Principal investigator, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835713
- Sponsor's protocol ID
- SMC 2023-02-076
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Intravenous Anesthesia for Rigid Bronchoscopy - Remimazolam Versus Propofol: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05835713
- Acronym / sponsor ID
- SMC 2023-02-076
- Conditions
- Respiratory Disease, Tracheal Stenosis, Endobronchial Mass
- Keywords
- Remimazolam, Rigid bronchoscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Identically designed study had been published before enrollment of first participant. Therefore, this study was not started. The IRB was approved the withdrawn of the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 28 Apr 2023 (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.
Rigid bronchoscopy usually requires deep general anesthesia, but the duration of the procedure is relatively short. Remimazolam, a recently developed anesthetics, showed faster recovery from anesthesia and stable hemodynamics compared to propofol, the most popular anesthetics. However, few studies have investigated the usefulness of remimazolam for rigid bronchoscopy. Therefore, the investigators compared the usefulness of propofol and remimazolam in total intravenous anesthesia for rigid bronchoscopy.
Detailed description
Rigid bronchoscopy usually requires deep general anesthesia, but the duration of the procedure is relatively short. Therefore, anesthesiologists need anesthetics that simultaneously provide hemodynamical stability and faster recovery from anesthesia. Remimazolam showed faster recovery from anesthesia and stable hemodynamic profiles compared to propofol, the most popular anesthetics during general anesthesia. However, few studies have investigated the usefulness of remimazolam during rigid bronchoscopy. In this randomized controlled trial, the investigators want to compare the recovery duration from anesthesia after a rigid bronchoscopy procedure between patients undergoing intravenous anesthesia using remimazolam and propofol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam besylate | Experimental | Drug: Remimazolam besylateRemimazolam group receive total intravenous anesthesia using remimazolam besylate and remifentanil during rigid bronchoscopy. Remimazolam group receive flumazenil during the emergence from anesthesia. |
| Propofol | Active comparator | Drug: PropofolPropofol group receive total intravenous anesthesia using propofol and remifentanil during rigid bronchoscopy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients who undergoing rigid bronchoscopy under general anesthesia in Samsung Medical Center, Seoul, South Korea
- American Society of Anesthesiologists physical status I, II, III
Key exclusion criteria (9 listed)
- patients who are contraindicated in benzodiazepine (e,g., allergy to the drug or have a history of hypersensitivity reactions)
- drug or alcohol addiction
- neuromuscular disease or mental illness
- metabolic disease
- emergency surgery
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 |
|---|---|---|
| Remimazolam besylateAlso: ByfavoRemimazolam group is induced general anesthesia using remimazolam besylate injection (0.2mg/kg bolus). General anesthesia is maintained using remimazolam infusion at a rate of 1mg/kg/h and remifentanil infusion at a rate of 0.05-0.15 mcg/kg/min. After recovering spontaneous respiration during emergence, remimazolam group receive flumazenil injection (0.5 mg) | Drug | Remimazolam besylate |
| PropofolPropofol group is induced general anesthesia using propofol injection (2 mg/kg bolus). General anesthesia is maintained using propofol infusion at a rate of 4-8 mg/kg/h and remifentanil infusion at a rate of 0.05-0.15 mcg/kg/min. | Drug | Propofol |
Primary outcome
The duration of emergence after rigid bronchoscopy
Time frame: From the end of anesthetics infusion to the extubation, an average of 10 minutes
The time interval between the end of anesthetics infusion and the extubation
3 secondary outcomes
The duration of induction before rigid bronchoscopy
Time frame: From the start of anesthetics infusion to the loss of responsiveness, an average of 5 minutes
Awareness during general anesthesia
Time frame: From the start of anesthetics infusion to the extubation, an average of 30 minutes
Use of vasoactive medication during rigid bronchoscopy
Time frame: From the start of anesthetics infusion to the extubation, an average of 30 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- 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.
Hyun Joo Ahn, MD, PhD principal investigator
Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam besylate and Propofol in people with Respiratory Disease and Tracheal Stenosis, run by Samsung Medical Center.
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 2 inclusion and 9 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: withdrawn, as of the sponsor's last update on 30 Mar 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 duration of emergence after rigid bronchoscopy (time frame: From the end of anesthetics infusion to the extubation, an average of 10 minutes). 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 30 Mar 2025.