Spine DiseaseNCT05453955
Effect of Remimazolam on Motor Evoked Potential
A study testing Propofol and Remimazolam Besylate in people with Spine Disease, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
This study was planned to investigate the degree of effect of remimazolam on MEP compared to propofol when monitoring the motion-inducing potential (MEP). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Spine Disease
- What is being tested?
- Propofol and Remimazolam Besylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2022to 7 Feb 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20-70
- Scheduled for elective spine surgery requiring monitoring of evoked potential
- ASA physical status 1-3
Who cannot join
- BMI ≥ 40
- Uncontrolled DM (HbA1c ≥ 9%)
- Contraindications to the study drug: known allergy or hypersensitivity
- Use of rate responsive cardiac pacemaker with bioelectrical impedence
- Diagnosed neuromuscular disorder
- Pre-existing motor weakness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Propofol and Remimazolam on Intraoperative Responses of Motor Evoked Potentials During Spine Surgery
This study was planned to investigate the degree of effect of remimazolam on MEP compared to propofol when monitoring the motion-inducing potential (MEP).
- Conditions
- Spine Disease
- Being tested
- Propofol, Remimazolam Besylate
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Remimazolam Besylate
Anesthesia induction and maintenance with propofol 60 minutes later, change the maintenance drug to remimazolam
Remimazolam BesylateDrug
Also called Propofol
Anesthesia induction and maintenance with remimazolam 60 minutes later, change the maintenance drug to propofol
| Study group | Role | What they receive |
|---|---|---|
| Propofol-Remimazolam | Experimental | General anesthesia was induced and maintained with propofol, then switched to remimazolam after 60 minutes from incision. Receives: Drug: Propofol; Drug: Remimazolam Besylate |
| Remimazolam-Propofol | Experimental | General anesthesia was induced and maintained with remimazolam, then changed to propofol after 60 minutes from incision. Receives: Drug: Propofol; Drug: Remimazolam Besylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor evoked potential (MEP), before cross-over
Amplitude and latency of MEP before cross-over
Measured: Intraoperative, just after confirmation of neuromuscular recovery, for 30 minutes
MEP, after cross-over
Amplitude and latency of MEP after cross-over
Measured: Intraoperative, 30 minutes after alteration of the maintenance drug, for 30 minutes
Secondary outcomes (3)
Bispectral index
Bispectral index during MEP data collection
Measured: Intraoperative
Blood pressure
Blood pressure during MEP data collection
Measured: Intraoperative
Heart rate
Heart rate during MEP data collection
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Aug 2022
- Primary completion2 Feb 2023
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DiseaseStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seok Kyeong Oh, Korea University Guro Hospital
- Investigators
- Sang Sik Choi, MD, PhD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453955
- Sponsor's protocol ID
- 2022GR0051
- Status last verified
- Mar 2023
- First submitted
- 8 Jul 2022
- Last updated
- 15 Mar 2023
- Results posted
- 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 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Propofol and Remimazolam on Intraoperative Responses of Motor Evoked Potentials During Spine Surgery
- ClinicalTrials.gov ID
- NCT05453955
- Acronym / sponsor ID
- 2022GR0051
- Conditions
- Spine Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 12 Jul 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.
This study was planned to investigate the degree of effect of remimazolam on MEP compared to propofol when monitoring the motion-inducing potential (MEP).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol-Remimazolam | Experimental | Drug: Propofol, Drug: Remimazolam BesylateGeneral anesthesia was induced and maintained with propofol, then switched to remimazolam after 60 minutes from incision. |
| Remimazolam-Propofol | Experimental | Drug: Propofol, Drug: Remimazolam BesylateGeneral anesthesia was induced and maintained with remimazolam, then changed to propofol after 60 minutes from incision. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 20-70
- Scheduled for elective spine surgery requiring monitoring of evoked potential
- ASA physical status 1-3
Key exclusion criteria (6 listed)
- BMI ≥ 40
- Uncontrolled DM (HbA1c ≥ 9%)
- Contraindications to the study drug: known allergy or hypersensitivity
- Use of rate responsive cardiac pacemaker with bioelectrical impedence
- Diagnosed neuromuscular disorder
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 |
|---|---|---|
| PropofolAlso: Remimazolam BesylateAnesthesia induction and maintenance with propofol 60 minutes later, change the maintenance drug to remimazolam | Drug | Propofol-Remimazolam, Remimazolam-Propofol |
| Remimazolam BesylateAlso: PropofolAnesthesia induction and maintenance with remimazolam 60 minutes later, change the maintenance drug to propofol | Drug | Propofol-Remimazolam, Remimazolam-Propofol |
Primary outcome
Motor evoked potential (MEP), before cross-over
Time frame: Intraoperative, just after confirmation of neuromuscular recovery, for 30 minutes
Amplitude and latency of MEP before cross-over
MEP, after cross-over
Time frame: Intraoperative, 30 minutes after alteration of the maintenance drug, for 30 minutes
Amplitude and latency of MEP after cross-over
3 secondary outcomes
Bispectral index
Time frame: Intraoperative
Blood pressure
Time frame: Intraoperative
Heart rate
Time frame: Intraoperative
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 15 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Sang Sik Choi, MD, PhD principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Remimazolam Besylate in people with Spine Disease, run by Korea University Guro 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 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 15 Mar 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?
Motor evoked potential (MEP), before cross-over (time frame: Intraoperative, just after confirmation of neuromuscular recovery, for 30 minutes). 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 15 Mar 2023.