Knee InjuriesPhase 4NCT02634021
Effect of Loading of Midazolam or Dexmedetomidine on Hemodynamics
A Phase 4 study testing dexmedetomidine group and midazolam group in people with Knee Injuries, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
Loading dose of dexmedetomidine is related hemodynamic instability such as bradycardia and hypertension. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Knee Injuries
- What is being tested?
- dexmedetomidine group and midazolam group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to Jul 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who were planned to undergo knee arthroscopy under spinal anesthesia
Who cannot join
- age < 20 years
- underlying heart, liver or kidney disease
- hypersensitivity to midazolam or dexmedetomidine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Change Between Loading of Dexmedetomidine or Midazolam as a Sedative Agents During Knee Arthroscopy
Loading dose of dexmedetomidine is related hemodynamic instability such as bradycardia and hypertension.
Read the detailed description
The investigators hypothesized substitution of loading of dexmedetomidine for midazolam could reduce hemodynamic instability during spinal anesthesia for knee arthroscopy.
- Conditions
- Knee Injuries
- Being tested
- dexmedetomidine group, midazolam group
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine groupDrug
Also called dexmedetomidine
intravenous loading of dexmedetomidine for 1 mcg/kg
midazolam groupDrug
Also called midazolam
intravenous loading of midazolam for 0.1 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine group | Active comparator | dexmedetomidine 1 mcg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr Receives: Drug: dexmedetomidine group |
| midazolam group | Experimental | midazolam 0.1 mg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr Receives: Drug: midazolam group |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of heart rate
Measured: from 1 minute before anesthesia to 1 hr after anesthesia
Secondary outcomes (1)
change of bispectral index
Measured: from 1 minute before anesthesia to 1 hr after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: The investigator had no more scientific interest about this issue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong-Hyop Kim, Konkuk University Medical Center
- Investigators
- Seong-Hyop Kim, Professor, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634021
- Sponsor's protocol ID
- KUH1160088
- Status last verified
- Apr 2021
- First submitted
- 9 Dec 2015
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Change Between Loading of Dexmedetomidine or Midazolam as a Sedative Agents During Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT02634021
- Acronym / sponsor ID
- KUH1160088
- Conditions
- Knee Injuries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigator had no more scientific interest about this issue.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 17 Dec 2015 (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.
Loading dose of dexmedetomidine is related hemodynamic instability such as bradycardia and hypertension.
Detailed description
The investigators hypothesized substitution of loading of dexmedetomidine for midazolam could reduce hemodynamic instability during spinal anesthesia for knee arthroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine group | Active comparator | Drug: dexmedetomidine groupdexmedetomidine 1 mcg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr |
| midazolam group | Experimental | Drug: midazolam groupmidazolam 0.1 mg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who were planned to undergo knee arthroscopy under spinal anesthesia
Key exclusion criteria (3 listed)
- age < 20 years
- underlying heart, liver or kidney disease
- hypersensitivity to midazolam or dexmedetomidine
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 |
|---|---|---|
| dexmedetomidine groupAlso: dexmedetomidineintravenous loading of dexmedetomidine for 1 mcg/kg | Drug | dexmedetomidine group |
| midazolam groupAlso: midazolamintravenous loading of midazolam for 0.1 mg/kg | Drug | midazolam group |
Primary outcome
change of heart rate
Time frame: from 1 minute before anesthesia to 1 hr after anesthesia
1 secondary outcome
change of bispectral index
Time frame: from 1 minute before anesthesia to 1 hr after anesthesia
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 20 Apr 2021.
- 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.
Seong-Hyop Kim, Professor principal investigator
Konkuk University Medical Center
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 dexmedetomidine group and midazolam group in people with Knee Injuries, run by Konkuk University 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 3 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 20 Apr 2021. 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.
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?
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?
change of heart rate (time frame: from 1 minute before anesthesia to 1 hr after anesthesia). 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 20 Apr 2021.