Hemodynamic InstabilityPhase 4NCT05644483
Effect of Remimazolam and Propofol on Hemodynamic Stability in Prone Position
A Phase 4 study testing Remimazolam and Propofol in people with Hemodynamic Instability, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Most of the major spinal surgeries are performed in the supine position, which causes a decrease in stroke volume and cardiac index, which leads to the occurrence of hypotension during surgery. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Remimazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Mar 2022to 25 Jan 2023
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status: 1-3
- age: 19-80 years
- patients who are scheduled to undergo a major spine surgery in the prone position
Who cannot join
- patients who refuse to participate
- body mass index: <15kg/m2 or >35kg/m2
- patients with uncontrolled hypertension, hyperthyroidism, severe cardiac disease
- patients who are contraindicated to the use of remimazolam including severe hepatic disease, acute glaucoma, shock, acute alcohol intoxication
- allergic to propofol and midazolam
- patients who are judged unsuitable to participate in the study for other reasons by medical staffs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Remimazolam-remifentanil Versus Propofol-remifentanil Based General Anesthesia on Intraoperative Hemodynamic Stability in Prone Position for Major Spine Surgery: a Randomized Controlled Trial
Most of the major spinal surgeries are performed in the supine position, which causes a decrease in stroke volume and cardiac index, which leads to the occurrence of hypotension during surgery. Postoperative hypotension causes an imbalance in the supply and demand of oxygen, leading to postoperative myocardial infarction or acute renal damage, and may increase mortality one year after surgery. Propofol, which is most commonly used for total intravenous anesthesia, can further increase the incidence of hypotension during surgery. Therefore, there is a continuing demand for an anesthetic agent that is more hemodynamically stable. Remimazolam, an ultra-short acting benzodiazepine that has a similar structure to midazolam, but whose activity is terminated by esterase hydrolysis, is expected to have less hemodynamic effects than propofol. Therefore, the purpose of this study is to investigate the effect of general anesthesia using remimazolam and general anesthesia using propofol on hemodynamic safety during surgery in patients undergoing major spinal surgery in the supine position.
- Conditions
- Hemodynamic Instability
- Being tested
- Remimazolam, Propofol
- Keywords
- propofol, remimazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Remimazolam: loading (6mg/kg/hr) + continuous infusion (1-2mg/kg/hr)
PropofolDrug
Propofol: target controlled infusion: 2-3mcg/mL
| Study group | Role | What they receive |
|---|---|---|
| remimazolam group | Experimental | patients who receive remimazolam-remifentanil based total intravenous anesthesia Receives: Drug: Remimazolam |
| propofol group | Active comparator | patients who receive propofol-remifentanil based total intravenous anesthesia Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of hypotensive episode per patient
SAP < baseline SBP * 80% or 90mmHg // MAP < baseline MAP * 80% or 65mmHg
Measured: for one hour after turning the patients to the prone position
the number of severe hypotensive episode per patient
SAP < baseline SBP * 70% or 80mmHg // MAP < baseline MAP * 70% or 55mmHg
Measured: for one hour after turning the patients to the prone position
Secondary outcomes (7)
cardiac index
cardiac index from Flotrac
Measured: for one hour after turning the patients to the prone position
pleth variability index
pleth variability index
Measured: for one hour after turning the patients to the prone position
heart rate
heart rate from EKG
Measured: for one hour after turning the patients to the prone position
Total opioid consumption
amount of total opioid administered
Measured: for one hour after turning the patients to the prone position
cardiac output
cardiac output from Flotrac
Measured: for one hour after turning the patients to the prone position
stroke volume
stroke volume from Flotrac
Measured: for one hour after turning the patients to the prone position
stroke volume variation
stroke volume variation from Flotrac
Measured: for one hour after turning the patients to the prone position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start29 Mar 2022
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Asan 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajung Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644483
- Sponsor's protocol ID
- 2021-1514
- Status last verified
- Feb 2025
- First submitted
- 3 Nov 2021
- Last updated
- 26 Feb 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remimazolam-remifentanil Versus Propofol-remifentanil Based General Anesthesia on Intraoperative Hemodynamic Stability in Prone Position for Major Spine Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05644483
- Acronym / sponsor ID
- 2021-1514
- Conditions
- Hemodynamic Instability
- Keywords
- propofol, remimazolam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 9 Dec 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.
Most of the major spinal surgeries are performed in the supine position, which causes a decrease in stroke volume and cardiac index, which leads to the occurrence of hypotension during surgery. Postoperative hypotension causes an imbalance in the supply and demand of oxygen, leading to postoperative myocardial infarction or acute renal damage, and may increase mortality one year after surgery. Propofol, which is most commonly used for total intravenous anesthesia, can further increase the incidence of hypotension during surgery. Therefore, there is a continuing demand for an anesthetic agent that is more hemodynamically stable. Remimazolam, an ultra-short acting benzodiazepine that has a similar structure to midazolam, but whose activity is terminated by esterase hydrolysis, is expected to have less hemodynamic effects than propofol. Therefore, the purpose of this study is to investigate the effect of general anesthesia using remimazolam and general anesthesia using propofol on hemodynamic safety during surgery in patients undergoing major spinal surgery in the supine position.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remimazolam group | Experimental | Drug: Remimazolampatients who receive remimazolam-remifentanil based total intravenous anesthesia |
| propofol group | Active comparator | Drug: Propofolpatients who receive propofol-remifentanil based total intravenous anesthesia |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status: 1-3
- age: 19-80 years
- patients who are scheduled to undergo a major spine surgery in the prone position
Key exclusion criteria (6 listed)
- patients who refuse to participate
- body mass index: <15kg/m2 or >35kg/m2
- patients with uncontrolled hypertension, hyperthyroidism, severe cardiac disease
- patients who are contraindicated to the use of remimazolam including severe hepatic disease, acute glaucoma, shock, acute alcohol intoxication
- allergic to propofol and midazolam
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 |
|---|---|---|
| RemimazolamRemimazolam: loading (6mg/kg/hr) + continuous infusion (1-2mg/kg/hr) | Drug | remimazolam group |
| PropofolPropofol: target controlled infusion: 2-3mcg/mL | Drug | propofol group |
Primary outcome
the number of hypotensive episode per patient
Time frame: for one hour after turning the patients to the prone position
SAP < baseline SBP * 80% or 90mmHg // MAP < baseline MAP * 80% or 65mmHg
the number of severe hypotensive episode per patient
Time frame: for one hour after turning the patients to the prone position
SAP < baseline SBP * 70% or 80mmHg // MAP < baseline MAP * 70% or 55mmHg
7 secondary outcomes
cardiac index
Time frame: for one hour after turning the patients to the prone position
pleth variability index
Time frame: for one hour after turning the patients to the prone position
heart rate
Time frame: for one hour after turning the patients to the prone position
Total opioid consumption
Time frame: for one hour after turning the patients to the prone position
cardiac output
Time frame: for one hour after turning the patients to the prone position
stroke volume
Time frame: for one hour after turning the patients to the prone position
stroke volume variation
Time frame: for one hour after turning the patients to the prone position
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 26 Feb 2025.
- Individual participant dataSharing planned: No
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Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
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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 Phase 4 study testing Remimazolam and Propofol in people with Hemodynamic Instability, run by Asan Medical Center 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 6 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 26 Feb 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
the number of hypotensive episode per patient (time frame: for one hour after turning the patients to the prone position). The study lists 2 primary outcomes in all. 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 26 Feb 2025.