TonsillitisNCT03337672
Comparison of Dexmedetomidine and Midazolam for Prevention of Emergence Delirium in Children
A study testing Dexmedetomidine and Midazolam in people with Tonsillitis, run by Eunah Cho, MD at 1 site in South Korea.
Trial summary
Emergence delirium is a common complication in children after anesthesia. The incidence of emergence delirium is reported upto 50%. Prevention of emergence delirium in children is important not only for the patient safety but also for the satisfaction of the parents. Read more about this study
- Who is it for?
- Ages 24 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Tonsillitis
- What is being tested?
- Dexmedetomidine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Dec 2017to 17 Dec 2018
- 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 24 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients undergoing elective tonsillectomy under general anesthesia
- American society of anesthesiologist physical status 1,2
- aged from 24 months to 12 years old
- obtaining written informed consent
Who cannot join
- known history of allergy to dexmedetomidine or midazolam
- renal impairment
- hepatic impairment
- long QT syndrome
- developmental disorder
- congenital disorder
- neurologic disorder
- psychogenic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Emergence delirium is a common complication in children after anesthesia. The incidence of emergence delirium is reported upto 50%. Prevention of emergence delirium in children is important not only for the patient safety but also for the satisfaction of the parents. Midazolam is the most commonly used medications for prevention of emergence delirium. However, it might lead to delayed awakening from anesthesia and respiratory depression. In this study, the investigators will evaluate whether dexmedetomidine can be effectively and safely administered for prevention of emergence delirium in children compared to midazolam.
Read the detailed description
In this study, seventy patients scheduled for elective tonsillectomy aged from 24 months to 12 years old Anesthesiologists physical status (ASA) class 1 and 2 will be enrolled. The sample size was calculated based on the former study with a type 1 error estimate of 0.05 at 80% power. The proportion in dexmedetomidine group (group D) was assumed to be 0.4 and the proportion in midazolam group (group M) was 0.1. Considering the drop-out rate of 10%, seventy patients in total were needed.The patients will randomly be allocated into the group D or the group M. The group D will receive dexmedetomidine0.3mcg/kg mixed with 0.9% normal saline, 10mL in total. The group M will receive 0.03mg/kg of midazolam mixed with 0.9% normal saline, 10mL in total. Randomization and drug administration will be done by a single anesthesiologist. Assessment of the patient will be done by another anesthesiologist blinded by the group. Five minutes before the end of the surgery, the study drug will be slowly infused for 5 minutes. In the postanesthesia circuit unit (PACU), presence of emergence delirium will be assessed. The emergence delirium will be assessed by the four-point agitation scale. (1 = calm, 2 = not calm but gould be easily calmed, 3 = not easily calmed, moderately agitated or restless, and 4 = combative, exited or disoriented.) Patients with score 3 and 4 will be diagnosed as emergence delirium and treated with intravenous fentanyl 1mcg/kg. Severity of emergence delirium will be assessed with the pediatric anesthesia emergence delirium scale after 10 mins on arrival of PACU. Pain wil be scored by 5-point scale (0 = no pain, 5 = severe pain ever). Time from discontinuation of anesthetic gas to extubate will be recorded. The data will be compared between the groups by the independent t-test or Mann-Whitney test for the continuous variables. Chi-square test or Fisher's exact test will be used for the categorial variables.
- Conditions
- Tonsillitis
- Being tested
- Dexmedetomidine, Midazolam
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Intravenous dexmedetomidine 0.3mcg/kg is slowly infused at 5 minutes before the end of surgery
MidazolamDrug
Intravenous dexmedetomidine 0.03mg/kg is slowly infused at 5 minutes before the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Subjects who receive dexmedetomidine for prevention of emergence delirium Receives: Drug: Dexmedetomidine |
| Midazolam group | Active comparator | Subjects who receive midazolam for prevention of emergence delirium Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Emergence Delirium (ED)
During the PACU stay, the patients will be assessed whether the emergence delirium (ED) occurred. It is defined as ED, if the highest score is more than 3 points after five time point measurements by the four-point agitation scale (1=calm, 2=not calm but easily calmed, 3=not easily calmed, moderately agitated, and 4=combative, excited, disoriented). The five time points are the 0 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes after arrival at the PACU.
Measured: 0 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes after arrival at the PACU
Secondary outcomes (2)
Severity of Emergence Delirium
Patients will be scored using the pediatric anesthesia emergence delirium scale. This consists of 5 criteria, each of which is pointed from 0 to 5 according to the severity. Total score stands for the delirium severity.
Measured: 10 minutes after arrival at the PACU
Emergence time
Time from the discontinuation of the anesthetic gas to extubation.
Measured: 3 minutes after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start5 Dec 2017
- Primary completion17 Dec 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillitisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunah Cho, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eunah Cho, MD, Kangbuk Samsung Hospital
- Investigators
- Eunah Cho, M.D., Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337672
- Sponsor's protocol ID
- 2017-04-038-001
- Status last verified
- Jan 2019
- First submitted
- 1 Nov 2017
- Last updated
- 9 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dexmedetomidine and Midazolam for Prevention of Emergence Delirium in Children
- ClinicalTrials.gov ID
- NCT03337672
- Acronym / sponsor ID
- 2017-04-038-001
- Conditions
- Tonsillitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Eunah Cho, MDUniversity, hospital or other
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 9 Nov 2017 (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.
Emergence delirium is a common complication in children after anesthesia. The incidence of emergence delirium is reported upto 50%. Prevention of emergence delirium in children is important not only for the patient safety but also for the satisfaction of the parents. Midazolam is the most commonly used medications for prevention of emergence delirium. However, it might lead to delayed awakening from anesthesia and respiratory depression. In this study, the investigators will evaluate whether dexmedetomidine can be effectively and safely administered for prevention of emergence delirium in children compared to midazolam.
Detailed description
In this study, seventy patients scheduled for elective tonsillectomy aged from 24 months to 12 years old Anesthesiologists physical status (ASA) class 1 and 2 will be enrolled. The sample size was calculated based on the former study with a type 1 error estimate of 0.05 at 80% power. The proportion in dexmedetomidine group (group D) was assumed to be 0.4 and the proportion in midazolam group (group M) was 0.1. Considering the drop-out rate of 10%, seventy patients in total were needed.The patients will randomly be allocated into the group D or the group M. The group D will receive dexmedetomidine0.3mcg/kg mixed with 0.9% normal saline, 10mL in total. The group M will receive 0.03mg/kg of midazolam mixed with 0.9% normal saline, 10mL in total. Randomization and drug administration will be done by a single anesthesiologist. Assessment of the patient will be done by another anesthesiologist blinded by the group. Five minutes before the end of the surgery, the study drug will be slowly infused for 5 minutes. In the postanesthesia circuit unit (PACU), presence of emergence delirium will be assessed. The emergence delirium will be assessed by the four-point agitation scale. (1 = calm, 2 = not calm but gould be easily calmed, 3 = not easily calmed, moderately agitated or restless, and 4 = combative, exited or disoriented.) Patients with score 3 and 4 will be diagnosed as emergence delirium and treated with intravenous fentanyl 1mcg/kg. Severity of emergence delirium will be assessed with the pediatric anesthesia emergence delirium scale after 10 mins on arrival of PACU. Pain wil be scored by 5-point scale (0 = no pain, 5 = severe pain ever). Time from discontinuation of anesthetic gas to extubate will be recorded. The data will be compared between the groups by the independent t-test or Mann-Whitney test for the continuous variables. Chi-square test or Fisher's exact test will be used for the categorial variables.
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 |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidineSubjects who receive dexmedetomidine for prevention of emergence delirium |
| Midazolam group | Active comparator | Drug: MidazolamSubjects who receive midazolam for prevention of emergence delirium |
Who may qualify
- Ages
- 24 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients undergoing elective tonsillectomy under general anesthesia
- American society of anesthesiologist physical status 1,2
- aged from 24 months to 12 years old
- obtaining written informed consent
Key exclusion criteria (8 listed)
- known history of allergy to dexmedetomidine or midazolam
- renal impairment
- hepatic impairment
- long QT syndrome
- developmental disorder
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 |
|---|---|---|
| DexmedetomidineIntravenous dexmedetomidine 0.3mcg/kg is slowly infused at 5 minutes before the end of surgery | Drug | Dexmedetomidine group |
| MidazolamIntravenous dexmedetomidine 0.03mg/kg is slowly infused at 5 minutes before the end of surgery | Drug | Midazolam group |
Primary outcome
Presence of Emergence Delirium (ED)
Time frame: 0 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes after arrival at the PACU
During the PACU stay, the patients will be assessed whether the emergence delirium (ED) occurred. It is defined as ED, if the highest score is more than 3 points after five time point measurements by the four-point agitation scale (1=calm, 2=not calm but easily calmed, 3=not easily calmed, moderately agitated, and 4=combative, excited, disoriented). The five time points are the 0 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes after arrival at the PACU.
2 secondary outcomes
Severity of Emergence Delirium
Time frame: 10 minutes after arrival at the PACU
Emergence time
Time frame: 3 minutes after extubation
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 9 Jan 2019.
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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.
Eunah Cho, M.D. principal investigator
Kangbuk Samsung 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 Dexmedetomidine and Midazolam in people with Tonsillitis, run by Eunah Cho, MD 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 4 inclusion and 8 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 9 Jan 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 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?
Presence of Emergence Delirium (ED) (time frame: 0 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes after arrival at the PACU). 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 9 Jan 2019.