ChildNCT01680471
A Study on the Effects of Midazolam on Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery
A study testing Midazolam 0.03mg/kg and Midazolam 0.05mg/kg in people with Child and Anesthesia Morbidity, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
Sevoflurane with its rapid induction and emergence, hemodynamic stability, and nonirritating airway properties, has acquired widespread acceptance in children. However, sevoflurane has been reported to be associated with emergence agitation in children, with a reported incidence of up to 80%. Read more about this study
- Who is it for?
- Ages 1 year to 13 years
- Conditions the study is for
- Child, Anesthesia Morbidity, Delirium on Emergence
- What is being tested?
- Midazolam 0.03mg/kg and Midazolam 0.05mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Nov 2012
- 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 1 year to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists physical status I and II patients
- Aged one to 13 years scheduled to undergo strabismus surgery under general anesthesia
- Willing to be assigned to any of the study intervention groups
Who cannot join
- Refusal by parents
- Neurological disease
- Developmental delay
- History of any previous surgery
- Airway disease
- American Society of Anesthesiologists physical status score of III or IV
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anaesthesiology and Pain Medicine Department; Korea University Anam Hospital
Seoul, 136-705
About this study
Official title: Comparative Study on the Effects of Capacities of Midazolam on Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery : a Randomized Double- Blinded Trial
Sevoflurane with its rapid induction and emergence, hemodynamic stability, and nonirritating airway properties, has acquired widespread acceptance in children. However, sevoflurane has been reported to be associated with emergence agitation in children, with a reported incidence of up to 80%.
The purpose of this study is to verify that the prophylactic use of midazolam, which is a GABA A receptor inhibitor, given five minutes before the end of strabismus surgery reduces the incidence of emergence agitation after sevoflurane anesthesia in children. Simultaneously, this study aims to find out the proper dose of midazolam with minimum disturbance to patient's emergence time.
Read the detailed description
Sevoflurane is associated with a high incidence of emergence agitation in children. The etiology of emergence agitation is unclear. Some studies proposed that emergence agitation was related to a variable rate of neurologic recovery rate in different brain areas and immaturity of neurons. Inhalation anesthetics have been known to exert transient paradoxical excitatory effects in both animals and human patients, especially in children. The gamma(γ)-aminobutyric acid (GABA)A receptor is the target depressant effect site of most anesthetic drugs including sevoflurane. Midazolam acts on the benzodiazepine binding site of GABAA receptors and results in inhibitory effects on the central nervous system. The effect of midazolam premedication, as well as midazolam administration at the end of surgery, on suppressing emergence agitation has been studied. However, the effect of midazolam on emergence agitation is still controversial. This study aims to figure out the effect of midazolam at the end of surgery on emergence agitation during the recovery period, and find out the proper dose of midazolam with minimum disturbance to patient's emergence time.
- Conditions
- Child, Anesthesia Morbidity, Delirium on Emergence
- Being tested
- Midazolam 0.03mg/kg, Midazolam 0.05mg/kg, Placebo
- Keywords
- emergence agitation, midazolam, sevoflurane, strabismus
- Medical subject headings
- Emergence Delirium, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam 0.03mg/kgDrug
Also called MIDAZOLAM BUKWANG INJ 5mg/5ml
This group will be injected intravenous midazolam 0.03mg/kg five minutes before the end of surgery.
If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg.
Midazolam 0.05mg/kgDrug
Also called MIDAZOLAM BUKWANG INJ 5mg/5ml
This group will be injected intravenous midazolam 0.05mg/kg five minutes before the end of surgery.
If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg.
PlaceboDrug
Also called NORMAL SALINE INJ(Sodium chloride 9g/1000mL)
This group will be injected intravenous normal saline five minutes before the end of surgery.
If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg.
| Study group | Role | What they receive |
|---|---|---|
| Midazolam 0.03mg/kg | Experimental | This group will be injected intravenous midazolam 0.03mg/kg five minutes before the end of surgery. Receives: Drug: Midazolam 0.03mg/kg |
| Midazolam 0.05mg/kg | Experimental | This group will be injected intravenous midazolam 0.05mg/kg five minutes before the end of surgery. Receives: Drug: Midazolam 0.05mg/kg |
| Placebo | Placebo comparator | This group will be injected intravenous normal saline five minutes before the end of surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of emergence
The time of emergence is defined as time interval from the time of discontinuation of sevoflurane to the time of extubation.
Measured: within the first 1hour after end of surgery
Secondary outcomes (1)
Incidence of emergency agitation
Agitation is assessed immediately after extubation, and continuously thereafter until participants are calm. Emergence agitation is evaluated using the four-point emergence scale and the pediatric anesthesia emergence delirium scale. The highest scores are recorded.
Measured: From just after extubation until the discharge of PACU, assessed up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Jung Cho, Korea University Anam Hospital
- Investigators
- Eun Jung Cho, Resident, Principal investigator, Department of Anaesthesiology and Pain Medicine Department, Korea University Anam HospitalS.Z. Yoon, Professor, Study director, Department of Anaesthesiology and Pain Medicine Department, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680471
- Sponsor's protocol ID
- ECho2012
- Status last verified
- Jan 2013
- First submitted
- 28 Aug 2012
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Effects of Capacities of Midazolam on Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery : a Randomized Double- Blinded Trial
- ClinicalTrials.gov ID
- NCT01680471
- Acronym / sponsor ID
- ECho2012
- Conditions
- Child, Anesthesia Morbidity, Delirium on Emergence
- Keywords
- emergence agitation, midazolam, sevoflurane, strabismus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 7 Sep 2012 (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.
Sevoflurane with its rapid induction and emergence, hemodynamic stability, and nonirritating airway properties, has acquired widespread acceptance in children. However, sevoflurane has been reported to be associated with emergence agitation in children, with a reported incidence of up to 80%.
The purpose of this study is to verify that the prophylactic use of midazolam, which is a GABA A receptor inhibitor, given five minutes before the end of strabismus surgery reduces the incidence of emergence agitation after sevoflurane anesthesia in children. Simultaneously, this study aims to find out the proper dose of midazolam with minimum disturbance to patient's emergence time.
Detailed description
Sevoflurane is associated with a high incidence of emergence agitation in children. The etiology of emergence agitation is unclear. Some studies proposed that emergence agitation was related to a variable rate of neurologic recovery rate in different brain areas and immaturity of neurons. Inhalation anesthetics have been known to exert transient paradoxical excitatory effects in both animals and human patients, especially in children. The gamma(γ)-aminobutyric acid (GABA)A receptor is the target depressant effect site of most anesthetic drugs including sevoflurane. Midazolam acts on the benzodiazepine binding site of GABAA receptors and results in inhibitory effects on the central nervous system. The effect of midazolam premedication, as well as midazolam administration at the end of surgery, on suppressing emergence agitation has been studied. However, the effect of midazolam on emergence agitation is still controversial. This study aims to figure out the effect of midazolam at the end of surgery on emergence agitation during the recovery period, and find out the proper dose of midazolam with minimum disturbance to patient's emergence time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Midazolam 0.03mg/kg | Experimental | Drug: Midazolam 0.03mg/kgThis group will be injected intravenous midazolam 0.03mg/kg five minutes before the end of surgery. |
| Midazolam 0.05mg/kg | Experimental | Drug: Midazolam 0.05mg/kgThis group will be injected intravenous midazolam 0.05mg/kg five minutes before the end of surgery. |
| Placebo | Placebo comparator | Drug: PlaceboThis group will be injected intravenous normal saline five minutes before the end of surgery. |
Who may qualify
- Ages
- 1 year to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status I and II patients
- Aged one to 13 years scheduled to undergo strabismus surgery under general anesthesia
- Willing to be assigned to any of the study intervention groups
Key exclusion criteria (6 listed)
- Refusal by parents
- Neurological disease
- Developmental delay
- History of any previous surgery
- Airway 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 |
|---|---|---|
| Midazolam 0.03mg/kgAlso: MIDAZOLAM BUKWANG INJ 5mg/5mlThis group will be injected intravenous midazolam 0.03mg/kg five minutes before the end of surgery. If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg. | Drug | Midazolam 0.03mg/kg |
| Midazolam 0.05mg/kgAlso: MIDAZOLAM BUKWANG INJ 5mg/5mlThis group will be injected intravenous midazolam 0.05mg/kg five minutes before the end of surgery. If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg. | Drug | Midazolam 0.05mg/kg |
| PlaceboAlso: NORMAL SALINE INJ(Sodium chloride 9g/1000mL)This group will be injected intravenous normal saline five minutes before the end of surgery. If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg. | Drug | Placebo |
Primary outcome
Time of emergence
Time frame: within the first 1hour after end of surgery
The time of emergence is defined as time interval from the time of discontinuation of sevoflurane to the time of extubation.
1 secondary outcome
Incidence of emergency agitation
Time frame: From just after extubation until the discharge of PACU, assessed up to 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
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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.
Eun Jung Cho, Resident principal investigator
Department of Anaesthesiology and Pain Medicine Department, Korea University Anam Hospital
S.Z. Yoon, Professor study director
Department of Anaesthesiology and Pain Medicine Department, Korea University Anam 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 Midazolam 0.03mg/kg and Midazolam 0.05mg/kg in people with Child and Anesthesia Morbidity, run by Korea University Anam 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 6 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 4 Jan 2013. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time of emergence (time frame: within the first 1hour after end of 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 4 Jan 2013.