Neurologic DisorderPhase 4NCT06382467
Comparison of Remimazolam and Propofol Combination vs. Propofol in IOM
A Phase 4 study testing Remimazolam besylate + propofol MCT and Propofol MCT in people with Neurologic Disorder, run by Chung-Ang University Gwangmyeong Hospital.
Trial summary
This study aims to compare total intravenous anesthetic agents: combined remimazolam and propofol vs. propofol monotherapy. The comparison parameters are intraoperative hypotension, patient's involuntary movement, neurophysiological monitoring quality, onset time, recovery time, and postoperative rescue anti-emetics… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Neurologic Disorder
- What is being tested?
- Remimazolam besylate + propofol MCT and Propofol MCT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19 and above with planned neurosurgical procedures requiring neurophysiological monitoring, classified as American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3 in the United States.
Who cannot join
- Patients who refuse to participate in the study.
- Patients who are pregnant or lactating.
- Patients with hypersensitivity to the investigational drugs or to soy, peanuts, or Dextran 40.
- Patients with acute narrow-angle glaucoma.
- Patients with alcohol or drug dependence.
- Patients with hepatic impairment classified as Child-Pugh class C.
- Patients with lactose intolerance.
- Patients requiring emergency surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Remimazolam and Propofol Combination vs. Propofol in Intraoperative Neurophysiologic Monitoring: A Randomized Controlled Trial
This study aims to compare total intravenous anesthetic agents: combined remimazolam and propofol vs. propofol monotherapy. The comparison parameters are intraoperative hypotension, patient's involuntary movement, neurophysiological monitoring quality, onset time, recovery time, and postoperative rescue anti-emetics requirements.
Read the detailed description
This study hypothesizes that the combination regimen of remimazolam and propofol as total intravenous anesthesia in neurosurgical procedures requiring neurophysiological monitoring can reduce the incidence of hypotension compared to propofol monotherapy while providing comparable levels of neurophysiological monitoring and surgical conditions. With this hypothesis, the study aims to compare the frequency, severity, and duration of hypotension, frequency of patient movement, and appropriateness of neurophysiological monitoring between the combination therapy of remimazolam and propofol and propofol monotherapy in total intravenous anesthesia.
- Conditions
- Neurologic Disorder
- Being tested
- Remimazolam besylate + propofol MCT, Propofol MCT
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylate + propofol MCTDrug
remimazolam besylate 3mg/kg/hr for induction, and 0.5 mg/kg/hr for maintenance + propofol MCT 1-4 mcg/ml using target-controlled infusion
Propofol MCTDrug
Propofol MCT 2-8 mcg/ml using target-controlled infusion
| Study group | Role | What they receive |
|---|---|---|
| Combination group | Experimental | Combination regimen (remimazolam plus propofol) Receives: Drug: Remimazolam besylate + propofol MCT |
| Propofol group | Active comparator | Propofol monotherapy Receives: Drug: Propofol MCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative hypotension
mean arterial pressure < 65mmHg
Measured: operation day - postoperative 1 day
Secondary outcomes (7)
Amount and number of inotropic agents
intraoperative inotropics amount (phenylephrine(mcg), ephedrine(mg), norepinephrine(mcg), dopamine(mg))
Measured: operation day - postoperative 1 day
Incidence of participants' intraoperative involuntary movement
number of patients involuntary movement during operation (ex. no movement:0 , 3 times of movement: 3)
Measured: operation day - postoperative 1 day
scores of neurophysiologic monitoring quality
0-5 scale of neurophysiologic monitoring quality, scored by neurophysiologic monitoring technologist (poor: 0, good: 5)
Measured: operation day - postoperative 1 day
onset time of study drugs
time from administration of study drugs(remimazolam+propofol or propofol) to Bispectral index value < 60
Measured: operation day - postoperative 1 day
The administration number of rescue anti-emetic agents
postoperative rescue anti-emetic agents (ramosetron, palonosetron, metoclopramide) requirements
Measured: operation day - postoperative 3 day
Time-weighted average of intraoperative hypotension
(depth of hypotension in millimeters of mercury below a MAP of 65mmHg × time in minutes spent below a MAP of 65mmHg)÷total duration of operation in minutes
Measured: operation day - postoperative 1 day
recovery time of study drugs (remimazolam+propofol or propofol)
time from discontinuation of study drugs(remimazolam+propofol or propofol) to Bispectral index value > 60
Measured: operation day - postoperative 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Gwangmyeong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiwon Han, Chung-Ang University Gwangmyeong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382467
- Sponsor's protocol ID
- 2401-136-016
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 24 Apr 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 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Remimazolam and Propofol Combination vs. Propofol in Intraoperative Neurophysiologic Monitoring: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06382467
- Acronym / sponsor ID
- 2401-136-016
- Conditions
- Neurologic Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Chung-Ang University Gwangmyeong HospitalUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 24 Apr 2024 (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.
This study aims to compare total intravenous anesthetic agents: combined remimazolam and propofol vs. propofol monotherapy. The comparison parameters are intraoperative hypotension, patient's involuntary movement, neurophysiological monitoring quality, onset time, recovery time, and postoperative rescue anti-emetics requirements.
Detailed description
This study hypothesizes that the combination regimen of remimazolam and propofol as total intravenous anesthesia in neurosurgical procedures requiring neurophysiological monitoring can reduce the incidence of hypotension compared to propofol monotherapy while providing comparable levels of neurophysiological monitoring and surgical conditions. With this hypothesis, the study aims to compare the frequency, severity, and duration of hypotension, frequency of patient movement, and appropriateness of neurophysiological monitoring between the combination therapy of remimazolam and propofol and propofol monotherapy in total intravenous anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination group | Experimental | Drug: Remimazolam besylate + propofol MCTCombination regimen (remimazolam plus propofol) |
| Propofol group | Active comparator | Drug: Propofol MCTPropofol monotherapy |
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 and above with planned neurosurgical procedures requiring neurophysiological monitoring, classified as American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3 in the United States.
Key exclusion criteria (8 listed)
- Patients who refuse to participate in the study.
- Patients who are pregnant or lactating.
- Patients with hypersensitivity to the investigational drugs or to soy, peanuts, or Dextran 40.
- Patients with acute narrow-angle glaucoma.
- Patients with alcohol or drug dependence.
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 + propofol MCTremimazolam besylate 3mg/kg/hr for induction, and 0.5 mg/kg/hr for maintenance + propofol MCT 1-4 mcg/ml using target-controlled infusion | Drug | Combination group |
| Propofol MCTPropofol MCT 2-8 mcg/ml using target-controlled infusion | Drug | Propofol group |
Primary outcome
Incidence of intraoperative hypotension
Time frame: operation day - postoperative 1 day
mean arterial pressure < 65mmHg
7 secondary outcomes
Amount and number of inotropic agents
Time frame: operation day - postoperative 1 day
Incidence of participants' intraoperative involuntary movement
Time frame: operation day - postoperative 1 day
scores of neurophysiologic monitoring quality
Time frame: operation day - postoperative 1 day
onset time of study drugs
Time frame: operation day - postoperative 1 day
The administration number of rescue anti-emetic agents
Time frame: operation day - postoperative 3 day
Time-weighted average of intraoperative hypotension
Time frame: operation day - postoperative 1 day
recovery time of study drugs (remimazolam+propofol or propofol)
Time frame: operation day - postoperative 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam besylate + propofol MCT and Propofol MCT in people with Neurologic Disorder, run by Chung-Ang University Gwangmyeong Hospital.
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 8 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: status not confirmed, as of the sponsor's last update on 24 Apr 2024. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiwon Han, Pf. (821034471988, yesuroon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intraoperative hypotension (time frame: operation day - postoperative 1 day). 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 24 Apr 2024.