Cerebral Ischemia-Hypoxia2NCT02966743
Effect of Sedatives on Regional Cerebral Oxygen Saturation
A study testing Midazolam and Dexmedetomidine in people with Cerebral Ischemia-Hypoxia, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine sedation for spinal anesthesia in the elderly patients who undergoing femur surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cerebral Ischemia-Hypoxia
- What is being tested?
- Midazolam and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2016to Oct 2017
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patinets who undergoing femur surgery under spinal anesthesia
Who cannot join
- previous cerebrovascular disease, uncontrolled cardiovascular disorder, uncontrolled pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Medazolam or Dexmedetomidine on Regional Cerebral Oxygen Saturation During Spinal Anesthesia in the Elderly Patients
Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine sedation for spinal anesthesia in the elderly patients who undergoing femur surgery.
Read the detailed description
Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine administration (target bispectrl index 75-80) for spinal anesthesia in the elderly patients over 65 years who undergoing femur surgery.
- Conditions
- Cerebral Ischemia-Hypoxia
- Being tested
- Midazolam, Dexmedetomidine
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Mida
administration of midazolam during spinal anesthesia for target bispectral index 75-80
DexmedetomidineDrug
Also called Dex
administration of dexmedetomidine during spinal anesthesia for target bispectral index 75-80
| Study group | Role | What they receive |
|---|---|---|
| midazolam | Experimental | administration of midazolam during spinal anesthesia for target bispectral index 75-80 Receives: Drug: Midazolam |
| dexmedetomidine | Active comparator | administration of dexmedeomidine during spinal anesthesia for target bispectral index 75-80 Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
regional cerebral oxygen saturation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Ischemia-HypoxiaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Yi Jo, Gachon University Gil Medical Center
- Investigators
- Youn Yi Jo, MD, Study director, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966743
- Sponsor's protocol ID
- GCIRB2016-293
- Acronym
- 2
- Status last verified
- Feb 2019
- First submitted
- 8 Nov 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medazolam or Dexmedetomidine on Regional Cerebral Oxygen Saturation During Spinal Anesthesia in the Elderly Patients
- ClinicalTrials.gov ID
- NCT02966743
- Acronym / sponsor ID
- 2 / GCIRB2016-293
- Conditions
- Cerebral Ischemia-Hypoxia
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 17 Nov 2016 (estimated)
- 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.
Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine sedation for spinal anesthesia in the elderly patients who undergoing femur surgery.
Detailed description
Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine administration (target bispectrl index 75-80) for spinal anesthesia in the elderly patients over 65 years who undergoing femur surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midazolam | Experimental | Drug: Midazolamadministration of midazolam during spinal anesthesia for target bispectral index 75-80 |
| dexmedetomidine | Active comparator | Drug: Dexmedetomidineadministration of dexmedeomidine during spinal anesthesia for target bispectral index 75-80 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- patinets who undergoing femur surgery under spinal anesthesia
Key exclusion criteria (1 listed)
- previous cerebrovascular disease, uncontrolled cardiovascular disorder, uncontrolled pulmonary disease
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 |
|---|---|---|
| MidazolamAlso: Midaadministration of midazolam during spinal anesthesia for target bispectral index 75-80 | Drug | midazolam |
| DexmedetomidineAlso: Dexadministration of dexmedetomidine during spinal anesthesia for target bispectral index 75-80 | Drug | dexmedetomidine |
Primary outcome
regional cerebral oxygen saturation
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- 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.
Youn Yi Jo, MD study director
Gachon University Gil Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam and Dexmedetomidine in people with Cerebral Ischemia-Hypoxia, run by Gachon University Gil Medical Center 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 15 Feb 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
regional cerebral oxygen saturation (time frame: 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 15 Feb 2019.