Intraoperative MovementPhase 4NCT05553678
The Effect of MDZ on Movement During UIA Clipping
A Phase 4 study testing Midazolam and Normal saline in people with Intraoperative Movement, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is a randomized, controlled, double-blinded, and parallel design study. A total 64 patients will be randomized to receive midazolam or normal saline during unruptured intracranial aneurysm clipping surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Intraoperative Movement
- What is being tested?
- Midazolam and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Sep 2022to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo elective unruptured intracranial aneurysm clipping surgery
- American Society of Anesthesiologists grade 1,2,3
- age > 18 year old
Who cannot join
- Refuse to participate to the study
- Body Mass Index < 18.5 kg/m2 or > 35 kg/m2
- Allergic history of benzodiazepine
- Pregnant
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 Midazolam on the Occurrence of Intraoperative Movement in Patients Undergoing Unruptured Intracranial Aneurysm Clipping Surgery: a Prospective Randomized Controlled Trial
This study is a randomized, controlled, double-blinded, and parallel design study. A total 64 patients will be randomized to receive midazolam or normal saline during unruptured intracranial aneurysm clipping surgery.
- Conditions
- Intraoperative Movement
- Being tested
- Midazolam, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Midazolam (0.03 mg/kg/30 min) will administered during UIA clipping through microscope.
Normal salineDrug
Normal saline (0.03 mg/ml/30 min) will administered during UIA clipping through microscope.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Midazolam (0.03 mg/kg/30 min) will administered during UIA clipping through microscope. Receives: Drug: Midazolam |
| Control group | Placebo comparator | Normal saline (0.03 ml/kg/30 min) will administered during UIA clipping through microscope. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative movement
Incidence
Measured: During microscopic surgery
Secondary outcomes (6)
Motor evoked potential amplitude
amplitude
Measured: immediately postoperative surgery
Motor evoked potential Latency
Latency
Measured: immediately postoperative surgery
Duration of mechanical ventilation time
duration
Measured: End of surgery to extubation time
Duration of ICU stay
duration of ICU stay, day
Measured: From date of ICU admission until the date of first discharge from ICU, assessed up to 1 week
Satisfaction score for intraoperative environment
using 11-point score (0=worst dissatisfied, 10=very sattisfied)
Measured: immediately postoperative surgery
Postoperative delirium
Incidence
Measured: Postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start29 Sep 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion31 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 MovementStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 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
- NCT05553678
- Sponsor's protocol ID
- UIA-MDZ
- Status last verified
- Oct 2022
- First submitted
- 18 Sep 2022
- Last updated
- 26 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 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Midazolam on the Occurrence of Intraoperative Movement in Patients Undergoing Unruptured Intracranial Aneurysm Clipping Surgery: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05553678
- Acronym / sponsor ID
- UIA-MDZ
- Conditions
- Intraoperative Movement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 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, double-blinded, and parallel design study. A total 64 patients will be randomized to receive midazolam or normal saline during unruptured intracranial aneurysm clipping surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: MidazolamMidazolam (0.03 mg/kg/30 min) will administered during UIA clipping through microscope. |
| Control group | Placebo comparator | Drug: Normal salineNormal saline (0.03 ml/kg/30 min) will administered during UIA clipping through microscope. |
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 unruptured intracranial aneurysm clipping surgery
- American Society of Anesthesiologists grade 1,2,3
- age > 18 year old
Key exclusion criteria (4 listed)
- Refuse to participate to the study
- 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 |
|---|---|---|
| MidazolamMidazolam (0.03 mg/kg/30 min) will administered during UIA clipping through microscope. | Drug | treatment group |
| Normal salineNormal saline (0.03 mg/ml/30 min) will administered during UIA clipping through microscope. | Drug | Control group |
Primary outcome
Intraoperative movement
Time frame: During microscopic surgery
Incidence
6 secondary outcomes
Motor evoked potential amplitude
Time frame: immediately postoperative surgery
Motor evoked potential Latency
Time frame: immediately postoperative surgery
Duration of mechanical ventilation time
Time frame: End of surgery to extubation time
Duration of ICU stay
Time frame: From date of ICU admission until the date of first discharge from ICU, assessed up to 1 week
Satisfaction score for intraoperative environment
Time frame: immediately postoperative surgery
Postoperative delirium
Time frame: Postoperative 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Intraoperative Movement
Enrolling by invitation
DBS Recordings to Characterize Movement Facilitation in Parkinson's Disease
Parkinson Disease
RecruitingObservational study
Intraoperative Microelectrode Recordings Using MAVEN Compared to Standard Recording Apparatuses
Essential Tremor, Parkinson's Disease
Recruiting
Simultaneous Bilateral Radiofrequency Thalamotomy for Medication-Refractory Essential Tremor
Essential Tremor
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 Phase 4 study testing Midazolam and Normal saline in people with Intraoperative Movement, 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 4 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 26 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. Some participants in this study may receive a placebo. 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 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 movement (time frame: During microscopic 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 26 Oct 2022.