Intraoperative HypotensionNCT05557253
Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery
A study testing Remimazolam and Balanced Anesthesia in people with Intraoperative Hypotension, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is a randomized, controlled trial. A total of 72 patients will be randomized to receive remimazolam anesthesia or balanced anesthesia (propofol + desflurane) during extracranial-intracranial bypass surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- Remimazolam and Balanced Anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Oct 2022to 30 Dec 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo elective extracranial-intracranial bypass surgery
- American Society of Anesthesiologists grade 1,2,3
- Age > 18 years old
Who cannot join
- Refuse to participate to the study
- American Society of Anesthesiologists grade 4
- Body Mass Index < 18.5 kg/m2 or > 35 kg/m2
- Allergic history of benzodiazepine
- Pregnant
- Acute narrow-angle glaucoma
Show all 12Show fewer
- Shock or Coma
- Acute alcohol addicted
- Obstructive sleep apnea
- dependency on alcohol or drug
- Severe acute respiratory insufficiency
- Hypersensitivity to Dextran 40
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Chang-Hoon Koo, vollock9@gmail.com
About this study
Official title: Effects of Remimazolam on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial
This study is a randomized, controlled trial. A total of 72 patients will be randomized to receive remimazolam anesthesia or balanced anesthesia (propofol + desflurane) during extracranial-intracranial bypass surgery.
- Conditions
- Intraoperative Hypotension
- Being tested
- Remimazolam, Balanced Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Anesthesia induction: remimazolam 6-12 mg/kg/h Anesthesia maintenance: remimazolam 1-2 mg/kg/h
Balanced AnesthesiaDrug
Anesthesia induction: propofol 1.5-2 mg/kg Anesthesia maintenance: Desflurane 6-8 vol%
| Study group | Role | What they receive |
|---|---|---|
| remimazolam group | Experimental | General anesthesia is induced and maintained with remimazolam. Receives: Drug: Remimazolam |
| balanced group | Active comparator | General anesthesia is induced with propofol and maintained with desflurane. Receives: Drug: Balanced Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative hypotension
Target Systolic Blood Pressure < 80%
Measured: During surgery
Secondary outcomes (6)
Inotropic requirements
Dose of inotropics administered during surgery
Measured: During surgery
Incidence of bradycardia
heart rate < 40 /min
Measured: During surgery
Incidence of tachycardia
heart rate > 100 /min
Measured: During surgery
Maximum systolic blood pressure
Maximal systolic blood pressure during surgery (mmHg)
Measured: During surgery
Minimum systolic blood pressure
Minimal systolic blood pressure during surgery (mmHg)
Measured: During surgery
Brain relaxation score
1=perfectly relaxed, 2=satisfactorily relaxed, 3=firm brain, 4=bulging brain
Measured: Immediately after dura opening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start20 Oct 2022
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Hoon Koo, Seoul National University Hospital
- Investigators
- Chang-Hoon Koo, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557253
- Sponsor's protocol ID
- Bypass-RMDZ
- Status last verified
- Oct 2022
- First submitted
- 25 Sep 2022
- Last updated
- 27 Oct 2022
- 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 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remimazolam on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05557253
- Acronym / sponsor ID
- Bypass-RMDZ
- Conditions
- Intraoperative Hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 27 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.
This study is a randomized, controlled trial. A total of 72 patients will be randomized to receive remimazolam anesthesia or balanced anesthesia (propofol + desflurane) during extracranial-intracranial bypass surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remimazolam group | Experimental | Drug: RemimazolamGeneral anesthesia is induced and maintained with remimazolam. |
| balanced group | Active comparator | Drug: Balanced AnesthesiaGeneral anesthesia is induced with propofol and maintained with desflurane. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who undergo elective extracranial-intracranial bypass surgery
- American Society of Anesthesiologists grade 1,2,3
- Age > 18 years old
Key exclusion criteria (12 listed)
- Refuse to participate to the study
- American Society of Anesthesiologists grade 4
- Body Mass Index < 18.5 kg/m2 or > 35 kg/m2
- Allergic history of benzodiazepine
- Pregnant
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 |
|---|---|---|
| RemimazolamAnesthesia induction: remimazolam 6-12 mg/kg/h Anesthesia maintenance: remimazolam 1-2 mg/kg/h | Drug | remimazolam group |
| Balanced AnesthesiaAnesthesia induction: propofol 1.5-2 mg/kg Anesthesia maintenance: Desflurane 6-8 vol% | Drug | balanced group |
Primary outcome
Intraoperative hypotension
Time frame: During surgery
Target Systolic Blood Pressure < 80%
6 secondary outcomes
Inotropic requirements
Time frame: During surgery
Incidence of bradycardia
Time frame: During surgery
Incidence of tachycardia
Time frame: During surgery
Maximum systolic blood pressure
Time frame: During surgery
Minimum systolic blood pressure
Time frame: During surgery
Brain relaxation score
Time frame: Immediately after dura opening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- 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.
Chang-Hoon Koo principal investigator
Seoul National University Bundang 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 Remimazolam and Balanced Anesthesia in people with Intraoperative Hypotension, run by Seoul National University 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 12 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 27 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang-Hoon Koo (+821085098841, vollock9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative hypotension (time frame: During surgery). 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 27 Oct 2022.