An interventional study of Dexmedetomidine and Midazolam in Tonsillitis, sponsored by Eunah Cho, MD. Completed at 1 site in Korea, Republic of. Open to participants aged 24 Months to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-09.
Sponsored by Eunah Cho, MD · Not applicable, Interventional, and Prevention
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.
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.
103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's enrollment of 70 is below the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →Eunah Cho, MD is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects who receive dexmedetomidine for prevention of emergence delirium
Drug: Dexmedetomidine
Subjects who receive midazolam for prevention of emergence delirium
Drug: Midazolam
Intravenous dexmedetomidine 0.3mcg/kg is slowly infused at 5 minutes before the end of surgery
Intravenous dexmedetomidine 0.03mg/kg is slowly infused at 5 minutes before the end of surgery
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.
Time frame: 0 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes after arrival at the PACU
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.
Time frame: 10 minutes after arrival at the PACU
Emergence time
Time from the discontinuation of the anesthetic gas to extubation.
Time frame: 3 minutes after extubation
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine
Eunah Cho, MD