Psychomotor AgitationNCT02256358
Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation
A study testing Midazolam and Ketamine in people with Psychomotor Agitation, run by Inje University.
Trial summary
Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Psychomotor Agitation
- What is being tested?
- Midazolam and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American society of anesthesiologists physical status 1-2 aged 2-6 years old, who were scheduled to undergo ophthalmic surgery (<2hr)
Who cannot join
- children with central nervous system disorders,history of allergy to the study drugs (midazolam and ketamine), history of recent respiratory tract infection
About this study
Official title: Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation : a Randomized Controlled Trial
Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia
Read the detailed description
Emergence agitation is self-limiting aggressive behavior that develops in the early period of awakening from anesthesia. A high level of preoperative anxiety is a risk factor for emergence agitation using Aono's four-point scale. Midazolam and ketamine was administered to the patients to decrease of preoperative anxiety. We aimed to compare the emergence agitation between midazolam group and ketamine group.
- Conditions
- Psychomotor Agitation
- Keywords
- child, ketamine, midazolam
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
preoperatively injected intravenous 0.1 mg/kg midazolam
KetamineDrug
Also called Ketamine HCl
Preoperatively injected intravenous 1mg/kg ketamine
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Active comparator | Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room. Receives: Drug: Midazolam |
| Ketamine | Experimental | Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence Agitation
The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.
Measured: During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psychomotor AgitationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Hwa Lee, Inje University
- Investigators
- Kihwa Lee, MD, Study chair, Haeundae paik hospital, inje university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256358
- Sponsor's protocol ID
- 2012-127
- Status last verified
- Oct 2014
- First submitted
- 1 Oct 2014
- Last updated
- 20 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02256358
- Acronym / sponsor ID
- 2012-127
- Conditions
- Psychomotor Agitation
- Keywords
- child, ketamine, midazolam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Posted 9 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia
Detailed description
Emergence agitation is self-limiting aggressive behavior that develops in the early period of awakening from anesthesia. A high level of preoperative anxiety is a risk factor for emergence agitation using Aono's four-point scale. Midazolam and ketamine was administered to the patients to decrease of preoperative anxiety. We aimed to compare the emergence agitation between midazolam group and ketamine group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Active comparator | Drug: MidazolamIntravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room. |
| Ketamine | Experimental | Drug: KetamineIntravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- American society of anesthesiologists physical status 1-2 aged 2-6 years old, who were scheduled to undergo ophthalmic surgery (<2hr)
Key exclusion criteria (1 listed)
- children with central nervous system disorders,history of allergy to the study drugs (midazolam and ketamine), history of recent respiratory tract infection
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 |
|---|---|---|
| Midazolampreoperatively injected intravenous 0.1 mg/kg midazolam | Drug | Midazolam |
| KetamineAlso: Ketamine HClPreoperatively injected intravenous 1mg/kg ketamine | Drug | Ketamine |
Primary outcome
Emergence Agitation
Time frame: During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes
The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kihwa Lee, MD study chair
Haeundae paik hospital, inje university
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam and Ketamine in people with Psychomotor Agitation, run by Inje University.
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: finished, as of the sponsor's last update on 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 9 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Emergence Agitation (time frame: During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes). 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 Oct 2014.