HemodynamicsNCT05201300
Remimazolam and Propofol Anesthesia in Elderly Patients
A study testing Remimazolam Besylate 6 mg/kg/hr, Remimazolam Besylate 12 mg/kg/hr and Propofol in people with Hemodynamics, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Remimazolam is a recently developed ultra-short agonist acting at the benzodiazepine binding site of the gamma-aminobutyric acid (GABA)A receptor. Remimazolam has a combination of the hemodynamic stability of benzodiazepines and the advantages of propofol, such as rapid onset, short duration of action, and improved… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hemodynamics
- What is being tested?
- Remimazolam Besylate 6 mg/kg/hr, Remimazolam Besylate 12 mg/kg/hr and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Feb 2022to 18 Jan 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ASA I, II patients over 65 years old undergoing general anesthesia
Who cannot join
- cardiac surgery
- neurosurgery
- liver surgery
- uncontrolled hypertension
- bronchial asthma
- body mass index ≥ 30 kg/m2
- severe heart, liver, kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Remimazolam and Propofol Anesthesia on Hemodynamic and Recovery Profile in Elderly Patients
Remimazolam is a recently developed ultra-short agonist acting at the benzodiazepine binding site of the gamma-aminobutyric acid (GABA)A receptor. Remimazolam has a combination of the hemodynamic stability of benzodiazepines and the advantages of propofol, such as rapid onset, short duration of action, and improved controllability.
A recent study showed that the efficacy of two induction doses of remimazolam (6 and 12 mg/kg/h) as a sedative for general anesthesia was not inferior to propofol (2.0-2.5 mg/kg), and hemodynamically more stable. On the other hand, a study on the emergence time and quality between propofol and remimazolam showed inconsistent results.
The purpose of this study is to compare remimazolam to propofol on the intraoperative hemodynamic changes and recovery profiles, when used in combination with remifentanil in elderly patients undergoing general anesthesia.
- Conditions
- Hemodynamics
- Being tested
- Remimazolam Besylate 6 mg/kg/hr, Remimazolam Besylate 12 mg/kg/hr, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam Besylate 6 mg/kg/hrDrug
Also called Byfavo
Patients will receive remimazolam at 6 mg/kg/hr by continuous infusion until loss of consciousness.
Remimazolam Besylate 12 mg/kg/hrDrug
Also called Byfavo
Patients will receive remimazolam at 12 mg/kg/hr by continuous infusion until loss of consciousness.
PropofolDrug
Also called Fresofol
Patients will receive propofol at a target controlled infusion 4 µg/ml until loss of consciousness.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam 6 | Experimental | Remimazolam starts at 6 mg/kg/hr until loss of consciousness Receives: Drug: Remimazolam Besylate 6 mg/kg/hr |
| Remimazolam 12 | Experimental | Remimazolam starts at 12 mg/kg/hr until loss of consciousness Receives: Drug: Remimazolam Besylate 12 mg/kg/hr |
| Propofol | Active comparator | Propofol starts at a target controlled infusion 4 µg/ml until loss of consciousness. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in the decreased mean arterial pressure
difference between baseline mean arterial pressure and lowest mean arterial pressure
Measured: from the start of anesthetics (propofol or remimazolam) injection to the 5 minutes after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start2 Feb 2022
- Primary completion25 Nov 2022
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodynamicsStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Yeop Kim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201300
- Sponsor's protocol ID
- AJIRB-MED-INT-21-651
- Status last verified
- Jul 2023
- First submitted
- 3 Jan 2022
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Remimazolam and Propofol Anesthesia on Hemodynamic and Recovery Profile in Elderly Patients
- ClinicalTrials.gov ID
- NCT05201300
- Acronym / sponsor ID
- AJIRB-MED-INT-21-651
- Conditions
- Hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 21 Jan 2022 (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.
Remimazolam is a recently developed ultra-short agonist acting at the benzodiazepine binding site of the gamma-aminobutyric acid (GABA)A receptor. Remimazolam has a combination of the hemodynamic stability of benzodiazepines and the advantages of propofol, such as rapid onset, short duration of action, and improved controllability.
A recent study showed that the efficacy of two induction doses of remimazolam (6 and 12 mg/kg/h) as a sedative for general anesthesia was not inferior to propofol (2.0-2.5 mg/kg), and hemodynamically more stable. On the other hand, a study on the emergence time and quality between propofol and remimazolam showed inconsistent results.
The purpose of this study is to compare remimazolam to propofol on the intraoperative hemodynamic changes and recovery profiles, when used in combination with remifentanil in elderly patients undergoing general anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remimazolam 6 | Experimental | Drug: Remimazolam Besylate 6 mg/kg/hrRemimazolam starts at 6 mg/kg/hr until loss of consciousness |
| Remimazolam 12 | Experimental | Drug: Remimazolam Besylate 12 mg/kg/hrRemimazolam starts at 12 mg/kg/hr until loss of consciousness |
| Propofol | Active comparator | Drug: PropofolPropofol starts at a target controlled infusion 4 µg/ml until loss of consciousness. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- ASA I, II patients over 65 years old undergoing general anesthesia
Key exclusion criteria (7 listed)
- cardiac surgery
- neurosurgery
- liver surgery
- uncontrolled hypertension
- bronchial asthma
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 Besylate 6 mg/kg/hrAlso: ByfavoPatients will receive remimazolam at 6 mg/kg/hr by continuous infusion until loss of consciousness. | Drug | Remimazolam 6 |
| Remimazolam Besylate 12 mg/kg/hrAlso: ByfavoPatients will receive remimazolam at 12 mg/kg/hr by continuous infusion until loss of consciousness. | Drug | Remimazolam 12 |
| PropofolAlso: FresofolPatients will receive propofol at a target controlled infusion 4 µg/ml until loss of consciousness. | Drug | Propofol |
Primary outcome
difference in the decreased mean arterial pressure
Time frame: from the start of anesthetics (propofol or remimazolam) injection to the 5 minutes after extubation
difference between baseline mean arterial pressure and lowest mean arterial pressure
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 25 Jul 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam Besylate 6 mg/kg/hr, Remimazolam Besylate 12 mg/kg/hr and Propofol in people with Hemodynamics, run by Ajou University School of Medicine 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 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: finished, as of the sponsor's last update on 25 Jul 2023. 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.
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?
difference in the decreased mean arterial pressure (time frame: from the start of anesthetics (propofol or remimazolam) injection to the 5 minutes after extubation). 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 25 Jul 2023.