Patients Undergoing NeurosurgeryNCT05164146
The Comparison of Hypotension Incidence Between Remimazolam and Propofol in Hypertensive Patients Undergoing Neurosurgery
A study testing propofol and remimazolam in people with Patients Undergoing Neurosurgery, run by Yonsei University at 1 site in South Korea.
Trial summary
This study aims to find an excellent drug in terms of hemodynamic stability when comparing the propofol and remifentanil with the combined use of remimazolam and remifentanil. When the mean blood pressure falls by 20% or more from the baseline mean blood pressure, it is considered hypotension, and a vasopressor such… Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients Undergoing Neurosurgery
- What is being tested?
- propofol and remimazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Feb 2022to 10 Aug 2022
- 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- hypertension
- patients undergoing neurosurgery
- ASA I-III
- 19-75 year-old patients
Who cannot join
- emergency
- Patients admitted on the day of surgery
- cardiac disease
- liver failure or liver cirrhosis
- increased intracranial pressure(IICP)
- mental change
- Foreigner
- iliteracy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
This study aims to find an excellent drug in terms of hemodynamic stability when comparing the propofol and remifentanil with the combined use of remimazolam and remifentanil. When the mean blood pressure falls by 20% or more from the baseline mean blood pressure, it is considered hypotension, and a vasopressor such as ephedrine, phenylephrine, or norpin is used to control the blood pressure to within 20% of the baseline blood pressure. If the blood pressure increases by 20% or more above the baseline mean blood pressure, nicardipine infusion or remimazolam, propofol or remifentanil should be increased to control the blood pressure.
- Conditions
- Patients Undergoing Neurosurgery
- Being tested
- propofol, remimazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
during the induction, remimazolam dose was controlled according to sedline (Psi target 40)
remimazolamDrug
During induction, remimazolam dose was controlled according to sedline (Psi target 40)
| Study group | Role | What they receive |
|---|---|---|
| propofol group | Active comparator | During the induction, propofol was controlled according to sedline (Psi target 40) Receives: Drug: propofol |
| remimazolam group | Experimental | During induction, remimazolam dose was controlled according to sedline (Psi target 40) Receives: Drug: remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hypotension events
Hypotension is considered when the mean blood pressure is 20% or more below the baseline mean blood pressure.
Measured: procedure (during induction before the surgery)
Secondary outcomes (3)
blood pressure
Blood pressure will be recorded from the start of drugs infusion to 10 minutes after intubation every 1 minutes, and they will be compared between two groups.
Measured: procedure (during induction before the surgery)
heart rate
heart rate will be recorded from the start of drugs infusion to 10 minutes after intubation every 1 minutes, and they will be compared between two groups.
Measured: procedure (during induction before the surgery)
sedline psi
sedline psi will be recorded from the start of drugs infusion to 10 minutes after intubation every 1 minutes, and they will be compared between two groups.
Measured: procedure (during induction before the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start23 Feb 2022
- Primary completion10 Aug 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing NeurosurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sujung Park, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164146
- Sponsor's protocol ID
- 4-2021-1456
- Status last verified
- Nov 2022
- First submitted
- 15 Dec 2021
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Choi SH, Min KT, Park EK, Park S. Comparison of hypotension incidence between remimazolam and propofol in patients with hypertension undergoing neurosurgery: prospective, randomized, single-blind trial. BMC Anesthesiol. 2024 Jun 4;24(1):198. doi: 10.1186/s12871-024-02578-7.
PubMed 38834996
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Hypotension Incidence Between Remimazolam and Propofol in Hypertensive Patients Undergoing Neurosurgery
- ClinicalTrials.gov ID
- NCT05164146
- Acronym / sponsor ID
- 4-2021-1456
- Conditions
- Patients Undergoing Neurosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 20 Dec 2021 (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 find an excellent drug in terms of hemodynamic stability when comparing the propofol and remifentanil with the combined use of remimazolam and remifentanil. When the mean blood pressure falls by 20% or more from the baseline mean blood pressure, it is considered hypotension, and a vasopressor such as ephedrine, phenylephrine, or norpin is used to control the blood pressure to within 20% of the baseline blood pressure. If the blood pressure increases by 20% or more above the baseline mean blood pressure, nicardipine infusion or remimazolam, propofol or remifentanil should be increased to control the blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol group | Active comparator | Drug: propofolDuring the induction, propofol was controlled according to sedline (Psi target 40) |
| remimazolam group | Experimental | Drug: remimazolamDuring induction, remimazolam dose was controlled according to sedline (Psi target 40) |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- hypertension
- patients undergoing neurosurgery
- ASA I-III
- 19-75 year-old patients
Key exclusion criteria (8 listed)
- emergency
- Patients admitted on the day of surgery
- cardiac disease
- liver failure or liver cirrhosis
- increased intracranial pressure(IICP)
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 |
|---|---|---|
| propofolduring the induction, remimazolam dose was controlled according to sedline (Psi target 40) | Drug | propofol group |
| remimazolamDuring induction, remimazolam dose was controlled according to sedline (Psi target 40) | Drug | remimazolam group |
Primary outcome
incidence of hypotension events
Time frame: procedure (during induction before the surgery)
Hypotension is considered when the mean blood pressure is 20% or more below the baseline mean blood pressure.
3 secondary outcomes
blood pressure
Time frame: procedure (during induction before the surgery)
heart rate
Time frame: procedure (during induction before the surgery)
sedline psi
Time frame: procedure (during induction before the surgery)
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 7 Nov 2022.
- Derived from this study: PubMed 38834996Choi SH, Min KT, Park EK, Park S. Comparison of hypotension incidence between remimazolam and propofol in patients with hypertension undergoing neurosurgery: prospective, randomized, single-blind trial. BMC Anesthesiol. 2024 Jun 4;24(1):198. doi: 10.1186/s12871-024-02578-7.
- Individual participant dataSharing planned: Undecided
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.
Sujung Park principal investigator
Severance 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 in people with Patients Undergoing Neurosurgery, run by Yonsei University 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 4 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: finished, as of the sponsor's last update on 7 Nov 2022. 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?
incidence of hypotension events (time frame: procedure (during induction before the surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05164146, which also lists 1 linked publication.
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 7 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.