Loss of ConsciousnessPhase 3NCT04901871
Remimazolam Bolus for General Anesthesia
A Phase 3 study testing 0.02 mg/kg, age<65, 0.07 mg/kg, age<65 and 0.12 mg/kg, age<65 in people with Loss of Consciousness, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
It is important to estimate the adequate dose of remimazolam intravenous bolus injection to induce the loss of consciousness. We will determine the ED50 and ED95 of remimazolam intravenous bolus on the loss of consciousness in patients undergoing general anesthesia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Loss of Consciousness
- What is being tested?
- 0.02 mg/kg, age<65, 0.07 mg/kg, age<65 and 0.12 mg/kg, age<65
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 May 2021to 26 Jul 2021
- Phase
- Phase 3
- 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
- Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for general anesthesia
Who cannot join
- Patients scheduled for liver surgery
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
- Liver disease
- Kidney disease
- Intolerance or hypersensitivity to benzodiazepine
Show all 13Show fewer
- Addiction
- Glaucoma
- Heart failure
- Peripheral vascular disease
- Obstuctive lung disease
- Patients scheduled for regional anesthesia before general anesthesia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ED50 and ED95 of Remimazolam Intravenous Bolus on the Loss of Consciousness in Patients Undergoing General Anesthesia
It is important to estimate the adequate dose of remimazolam intravenous bolus injection to induce the loss of consciousness. We will determine the ED50 and ED95 of remimazolam intravenous bolus on the loss of consciousness in patients undergoing general anesthesia.
- Conditions
- Loss of Consciousness
- Being tested
- 0.02 mg/kg, age<65, 0.07 mg/kg, age<65, 0.12 mg/kg, age<65, 0.17 mg/kg, age<65, 0.22 mg/kg, age<65
- Medical subject headings
- Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.02 mg/kg, age<65Drug
Remimazolam of 0.02 mg/kg will be infused in patients aged<65.
0.07 mg/kg, age<65Drug
Remimazolam of 0.07 mg/kg will be infused in patients aged<65.
0.12 mg/kg, age<65Drug
Remimazolam of 0.12 mg/kg will be infused in patients aged<65.
0.17 mg/kg, age<65Drug
Remimazolam of 0.17 mg/kg will be infused in patients aged<65.
0.22 mg/kg, age<65Drug
Remimazolam of 0.22 mg/kg will be infused in patients aged<65.
0.27 mg/kg, age<65Drug
Remimazolam of 0.27 mg/kg will be infused in patients aged<65.
0.02 mg/kg, age≥65Drug
Remimazolam of 0.02 mg/kg will be infused in patients aged≥65.
0.07 mg/kg, age≥65Drug
Remimazolam of 0.07 mg/kg will be infused in patients aged≥65.
0.12 mg/kg, age≥65Drug
Remimazolam of 0.12 mg/kg will be infused in patients aged≥65
0.17 mg/kg, age≥65Drug
Remimazolam of 0.17 mg/kg will be infused in patients aged≥65.
0.22 mg/kg, age≥65Drug
Remimazolam of 0.22 mg/kg will be infused in patients aged≥65.
0.27 mg/kg, age≥65Drug
Remimazolam of 0.27 mg/kg will be infused in patients aged≥65.
| Study group | Role | What they receive |
|---|---|---|
| 1 (0.02 mg/kg, age<65) | Active comparator | Remimazolam of 0.02 mg/kg will be infused in patients aged<65. Receives: Drug: 0.02 mg/kg, age<65 |
| 2 (0.07 mg/kg, age<65) | Active comparator | Remimazolam of 0.07 mg/kg will be infused in patients aged<65. Receives: Drug: 0.07 mg/kg, age<65 |
| 3 (0.12 mg/kg, age<65) | Active comparator | Remimazolam of 0.12 mg/kg will be infused in patients aged<65. Receives: Drug: 0.12 mg/kg, age<65 |
| 4 (0.17 mg/kg, age<65) | Active comparator | Remimazolam of 0.17 mg/kg will be infused in patients aged<65. Receives: Drug: 0.17 mg/kg, age<65 |
| 5(0.22 mg/kg, age<65) | Active comparator | Remimazolam of 0.22 mg/kg will be infused in patients aged<65. Receives: Drug: 0.22 mg/kg, age<65 |
| 6(0.27 mg/kg, age<65) | Active comparator | Remimazolam of 0.27 mg/kg will be infused in patients aged<65. Receives: Drug: 0.27 mg/kg, age<65 |
| 7 (0.02 mg/kg, age≥65) | Active comparator | Remimazolam of 0.02 mg/kg will be infused in patients aged≥65. Receives: Drug: 0.02 mg/kg, age≥65 |
| 8 (0.07 mg/kg, age≥65) | Active comparator | Remimazolam of 0.07 mg/kg will be infused in patients aged≥65. Receives: Drug: 0.07 mg/kg, age≥65 |
| 9 (0.12 mg/kg, age≥65) | Active comparator | Remimazolam of 0.12 mg/kg will be infused in patients aged≥65. Receives: Drug: 0.12 mg/kg, age≥65 |
| 10 (0.17 mg/kg, age≥65) | Active comparator | Remimazolam of 0.17 mg/kg will be infused in patients aged≥65. Receives: Drug: 0.17 mg/kg, age≥65 |
| 11 (0.22 mg/kg, age≥65) | Active comparator | Remimazolam of 0.22 mg/kg will be infused in patients aged≥65. Receives: Drug: 0.22 mg/kg, age≥65 |
| 12 (0.27 mg/kg, age≥65) | Active comparator | Remimazolam of 0.27 mg/kg will be infused in patients aged≥65. Receives: Drug: 0.27 mg/kg, age≥65 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of consciousness within 5 minutes
Loss of consciousness will be evaluated at 5 minutes after infusion.
Measured: At 5 minutes after infusion
Secondary outcomes (4)
Time to loss of consciousness
Time to loss of consciousness will be assessed at 5 minutes after infusion.
Measured: At 5 minutes after infusion (time to loss of consciousness)
blood pressure
Blood pressure will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.
Measured: At 5 minutes after infusion
heart rate
Heart rate will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.
Measured: At 5 minutes after infusion
sedline
Sedline will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.
Measured: At 5 minutes after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start27 May 2021
- Primary completion20 Jul 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Loss of ConsciousnessStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Woo Han, Gangnam Severance Hospital
- Investigators
- Dong Woo Han, Principal investigator, GangnamSeveracne Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901871
- Sponsor's protocol ID
- 3-2021-0091
- Status last verified
- Jul 2021
- First submitted
- 10 May 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chae D, Kim HC, Song Y, Choi YS, Han DW. Pharmacodynamic analysis of intravenous bolus remimazolam for loss of consciousness in patients undergoing general anaesthesia: a randomised, prospective, double-blind study. Br J Anaesth. 2022 Jul;129(1):49-57. doi: 10.1016/j.bja.2022.02.040. Epub 2022 May 11.
PubMed 35562226
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED50 and ED95 of Remimazolam Intravenous Bolus on the Loss of Consciousness in Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT04901871
- Acronym / sponsor ID
- 3-2021-0091
- Conditions
- Loss of Consciousness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 26 May 2021 (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.
It is important to estimate the adequate dose of remimazolam intravenous bolus injection to induce the loss of consciousness. We will determine the ED50 and ED95 of remimazolam intravenous bolus on the loss of consciousness in patients undergoing general anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| 1 (0.02 mg/kg, age<65) | Active comparator | Drug: 0.02 mg/kg, age<65Remimazolam of 0.02 mg/kg will be infused in patients aged<65. |
| 2 (0.07 mg/kg, age<65) | Active comparator | Drug: 0.07 mg/kg, age<65Remimazolam of 0.07 mg/kg will be infused in patients aged<65. |
| 3 (0.12 mg/kg, age<65) | Active comparator | Drug: 0.12 mg/kg, age<65Remimazolam of 0.12 mg/kg will be infused in patients aged<65. |
| 4 (0.17 mg/kg, age<65) | Active comparator | Drug: 0.17 mg/kg, age<65Remimazolam of 0.17 mg/kg will be infused in patients aged<65. |
| 5(0.22 mg/kg, age<65) | Active comparator | Drug: 0.22 mg/kg, age<65Remimazolam of 0.22 mg/kg will be infused in patients aged<65. |
| 6(0.27 mg/kg, age<65) | Active comparator | Drug: 0.27 mg/kg, age<65Remimazolam of 0.27 mg/kg will be infused in patients aged<65. |
| 7 (0.02 mg/kg, age≥65) | Active comparator | Drug: 0.02 mg/kg, age≥65Remimazolam of 0.02 mg/kg will be infused in patients aged≥65. |
| 8 (0.07 mg/kg, age≥65) | Active comparator | Drug: 0.07 mg/kg, age≥65Remimazolam of 0.07 mg/kg will be infused in patients aged≥65. |
| 9 (0.12 mg/kg, age≥65) | Active comparator | Drug: 0.12 mg/kg, age≥65Remimazolam of 0.12 mg/kg will be infused in patients aged≥65. |
| 10 (0.17 mg/kg, age≥65) | Active comparator | Drug: 0.17 mg/kg, age≥65Remimazolam of 0.17 mg/kg will be infused in patients aged≥65. |
| 11 (0.22 mg/kg, age≥65) | Active comparator | Drug: 0.22 mg/kg, age≥65Remimazolam of 0.22 mg/kg will be infused in patients aged≥65. |
| 12 (0.27 mg/kg, age≥65) | Active comparator | Drug: 0.27 mg/kg, age≥65Remimazolam of 0.27 mg/kg will be infused in patients aged≥65. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for general anesthesia
Key exclusion criteria (13 listed)
- Patients scheduled for liver surgery
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
- Liver disease
- Kidney disease
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 |
|---|---|---|
| 0.02 mg/kg, age<65Remimazolam of 0.02 mg/kg will be infused in patients aged<65. | Drug | 1 (0.02 mg/kg, age<65) |
| 0.07 mg/kg, age<65Remimazolam of 0.07 mg/kg will be infused in patients aged<65. | Drug | 2 (0.07 mg/kg, age<65) |
| 0.12 mg/kg, age<65Remimazolam of 0.12 mg/kg will be infused in patients aged<65. | Drug | 3 (0.12 mg/kg, age<65) |
| 0.17 mg/kg, age<65Remimazolam of 0.17 mg/kg will be infused in patients aged<65. | Drug | 4 (0.17 mg/kg, age<65) |
| 0.22 mg/kg, age<65Remimazolam of 0.22 mg/kg will be infused in patients aged<65. | Drug | 5(0.22 mg/kg, age<65) |
| 0.27 mg/kg, age<65Remimazolam of 0.27 mg/kg will be infused in patients aged<65. | Drug | 6(0.27 mg/kg, age<65) |
| 0.02 mg/kg, age≥65Remimazolam of 0.02 mg/kg will be infused in patients aged≥65. | Drug | 7 (0.02 mg/kg, age≥65) |
| 0.07 mg/kg, age≥65Remimazolam of 0.07 mg/kg will be infused in patients aged≥65. | Drug | 8 (0.07 mg/kg, age≥65) |
| 0.12 mg/kg, age≥65Remimazolam of 0.12 mg/kg will be infused in patients aged≥65 | Drug | 9 (0.12 mg/kg, age≥65) |
| 0.17 mg/kg, age≥65Remimazolam of 0.17 mg/kg will be infused in patients aged≥65. | Drug | 10 (0.17 mg/kg, age≥65) |
| 0.22 mg/kg, age≥65Remimazolam of 0.22 mg/kg will be infused in patients aged≥65. | Drug | 11 (0.22 mg/kg, age≥65) |
| 0.27 mg/kg, age≥65Remimazolam of 0.27 mg/kg will be infused in patients aged≥65. | Drug | 12 (0.27 mg/kg, age≥65) |
Primary outcome
Loss of consciousness within 5 minutes
Time frame: At 5 minutes after infusion
Loss of consciousness will be evaluated at 5 minutes after infusion.
4 secondary outcomes
Time to loss of consciousness
Time frame: At 5 minutes after infusion (time to loss of consciousness)
blood pressure
Time frame: At 5 minutes after infusion
heart rate
Time frame: At 5 minutes after infusion
sedline
Time frame: At 5 minutes after infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Derived from this study: PubMed 35562226Chae D, Kim HC, Song Y, Choi YS, Han DW. Pharmacodynamic analysis of intravenous bolus remimazolam for loss of consciousness in patients undergoing general anaesthesia: a randomised, prospective, double-blind study. Br J Anaesth. 2022 Jul;129(1):49-57. doi: 10.1016/j.bja.2022.02.040. Epub 2022 May 11.
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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.
Dong Woo Han principal investigator
GangnamSeveracne Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.02 mg/kg, age<65, 0.07 mg/kg, age<65 and 0.12 mg/kg, age<65 in people with Loss of Consciousness, run by Gangnam Severance Hospital at 1 site in South Korea.
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 1 inclusion and 13 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: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Loss of consciousness within 5 minutes (time frame: At 5 minutes after infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04901871, which also lists 1 linked publication.
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 28 Jul 2021.