HypotensionNCT05538741
Hypotension After Anesthetic Induction with Remimazolam in Elderly
A study testing Bolus of remimazolam and Continuous infusion of remimazolam in people with Hypotension, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
Even though remimazolam is known to be safely administered without hemodynamic instability, hypotension is the one of the common side effects of remimazolam. Because elderly patients are susceptible to hypotension due to old age, multimodality, and multiple medications, hypotension can be harmful in elderly patients. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypotension
- What is being tested?
- Bolus of remimazolam and Continuous infusion of remimazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jul 2023to 14 Jun 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly patients with age over 60 years old
- scheduled for elective surgery under general anesthesia
- American Society of Anesthesiology Physical Status I-III
Who cannot join
- Arrhythmia
- Liver dysfunction
- Kidney dysfunction
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
- Allergic to benzodiazepines
Show all 11Show fewer
- Heart failure
- Drug intoxication
- Alcoholics
- Cognitive dysfunction
- Unable to understand and consent voluntarily
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Incidence of Hypotension with Bolus Versus Continuous Remimazolam for Anesthetic Induction in Elderly Patients
Even though remimazolam is known to be safely administered without hemodynamic instability, hypotension is the one of the common side effects of remimazolam. Because elderly patients are susceptible to hypotension due to old age, multimodality, and multiple medications, hypotension can be harmful in elderly patients. Remimazolam can be administered either bolus or continuous for anesthetic induction. In our study the investigators aimed to compare the incidence of hypotension after anesthetic induction using remimazolam by bolus injection and continuous infusion in elderly patients.
- Conditions
- Hypotension
- Being tested
- Bolus of remimazolam, Continuous infusion of remimazolam
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bolus of remimazolamDrug
0.19-0.25 mg/kg for 60-80 years old 0.14-0.19 mg/kg for >80 years old
Continuous infusion of remimazolamDrug
12 mg/kg/hr until loss of consciousness
| Study group | Role | What they receive |
|---|---|---|
| Bolus | Experimental | Remimazolam bolus injection for 20 seconds Receives: Drug: Bolus of remimazolam |
| Continuous | Active comparator | Remimazolam continuous infusion Receives: Drug: Continuous infusion of remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hypotension
Systolic blood pressure < 90 mmHg
Measured: 10 minutes after intubation
Secondary outcomes (5)
The incidence of bradycardia
Heart rate < 40 beats per minute
Measured: 10 minutes after intubation
Number of participants with use of any vasopressors
Use of ephedrine, phenylephrine
Measured: 10 minutes after intubation
Lowest systolic blood pressure
The lowest systolic blood pressure measured within10 minutes after intubation
Measured: 10 minutes after intubation
Time to loss of consciousness
Time to loss of consciousness. Loss of consciousness is assessed by the loss of response to shoulder shaking.
Measured: 10 minutes after intubation
Total remimazolam used for anesthetic induction
Sum of remimazolam used during anesthetic induction
Measured: 10 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start14 Jul 2023
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eunah Cho, MD, Kangbuk Samsung Hospital
- Investigators
- Eunah Cho, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538741
- Sponsor's protocol ID
- RMZ_bolcon_old
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Incidence of Hypotension with Bolus Versus Continuous Remimazolam for Anesthetic Induction in Elderly Patients
- ClinicalTrials.gov ID
- NCT05538741
- Acronym / sponsor ID
- RMZ_bolcon_old
- Conditions
- Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 14 Sep 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.
Even though remimazolam is known to be safely administered without hemodynamic instability, hypotension is the one of the common side effects of remimazolam. Because elderly patients are susceptible to hypotension due to old age, multimodality, and multiple medications, hypotension can be harmful in elderly patients. Remimazolam can be administered either bolus or continuous for anesthetic induction. In our study the investigators aimed to compare the incidence of hypotension after anesthetic induction using remimazolam by bolus injection and continuous infusion in elderly patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bolus | Experimental | Drug: Bolus of remimazolamRemimazolam bolus injection for 20 seconds |
| Continuous | Active comparator | Drug: Continuous infusion of remimazolamRemimazolam continuous infusion |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elderly patients with age over 60 years old
- scheduled for elective surgery under general anesthesia
- American Society of Anesthesiology Physical Status I-III
Key exclusion criteria (11 listed)
- Arrhythmia
- Liver dysfunction
- Kidney dysfunction
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
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 |
|---|---|---|
| Bolus of remimazolam0.19-0.25 mg/kg for 60-80 years old 0.14-0.19 mg/kg for >80 years old | Drug | Bolus |
| Continuous infusion of remimazolam12 mg/kg/hr until loss of consciousness | Drug | Continuous |
Primary outcome
The incidence of hypotension
Time frame: 10 minutes after intubation
Systolic blood pressure < 90 mmHg
5 secondary outcomes
The incidence of bradycardia
Time frame: 10 minutes after intubation
Number of participants with use of any vasopressors
Time frame: 10 minutes after intubation
Lowest systolic blood pressure
Time frame: 10 minutes after intubation
Time to loss of consciousness
Time frame: 10 minutes after intubation
Total remimazolam used for anesthetic induction
Time frame: 10 minutes after intubation
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 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
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Not yet recruitingObservational study
Postprandial Hypotension, Frailty and Post-Induction Hypotension in Older Patients Undergoing Noncardiac Surgery
Post-induction Hypotension (PIH), Postprandial Hypotension
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.
Eunah Cho, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bolus of remimazolam and Continuous infusion of remimazolam in people with Hypotension, run by Kangbuk Samsung 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 3 inclusion and 11 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 19 Sep 2024. 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?
The incidence of hypotension (time frame: 10 minutes after intubation). 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 19 Sep 2024.