Comparison of Midazolam or Dexmedetomidine on Epileptiform EEG During Sevoflurane Mask Induction

Study Overview
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Brief Summary
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Induction with high sevoﬂurane concentrations may trigger epileptiform electroencephalographic activity without motor or cardiovascular manifestations in healthy patients. No other symptoms were associated in this series, and only electroencephalographic monitoring allowed the diagnosis. Midazolam and dexmedetomidine are sedatives commonly used in children before surgery. Although the mechanisms are different, both have been reported in antiepileptic effects. This study was designed to compare the effects between intranasal midazolam or dexmedetomidine on epileptiform EEG during sevoflurane mask induction in children. Anaesthesia was induced with 8% sevoﬂurane. The patients were randomly assigned to Group A (n=15, preoperative intranasal normal saline), Group B (n=15, preoperative intranasal 0.25mg/kg midazolam), and Group C (n=15, preoperative intranasal 1μg/kg dexmedetomidine). An electroencephalogram was recorded before and during induction up to 10 min after the start of induction.

Official Title
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Comparison of Intranasal Midazolam or Dexmedetomidine on Epileptiform EEG During Sevoflurane Mask Induction in Children

Conditions
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Inhalation Anesthesia

Intervention / Treatment
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* Drug: Placebos
* Drug: Midazolam
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status 1-2 Scheduled for general anesthesia Exclusion Criteria: Patients with a history of neurological, mental illnes Patients with a history of congenital heart disease Patients with a history of allergies to related drugs

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group A<br> | Drug: Placebos<br>* Patients in Group A receive intranasal normal saline before anesthesia. Anaesthesia was induced with 8% sevoﬂurane initially. Sevoflurane concentration decreased to 2% after intubation. An electroencephalogram was recorded before and during induction up to 10 min after the start of induction.<br>|
| Experimental: Group B<br> | Drug: Midazolam<br>* Patients in Group B receive intranasal 0.25mg/kg midazolam before anesthesia. Anaesthesia was induced with 8% sevoﬂurane initially. Sevoflurane concentration decreased to 2% after intubation. An electroencephalogram was recorded before and during induction up to 10 min after the start of induction.<br>|
| Experimental: Group C<br> | Drug: Dexmedetomidine<br>* Patients in Group C receive intranasal 1μg/kg dexmedetomidine before anesthesia. Anaesthesia was induced with 8% sevoﬂurane initially. Sevoflurane concentration decreased to 2% after intubation. An electroencephalogram was recorded before and during induction up to 10 min after the start of induction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of epileptiform EEG | EEG were visually analyzed off-line by a neurophysiologist familiar with anesthesia EEG and blinded to the randomization. EEG abnormalities related to epileptic features were classiﬁed according to the description of Vakkuri and Jaaskelainen, and the recommendations of Constant: spikes and spikes with slow wave complexes (SW), rhythmic polyspikes corresponding to waveforms appearing at regular intervals (RPS) and periodic epileptiform discharge (PED), which refers to periodic hypersynchronized complexes occurring bilaterally. These entire electroencephalographic phenomena were considered as epileptiform EEG if their duration was longer than three seconds. | 0 min after induction, up to 10 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electroencephalographic changes | the delay between the start of induction and the ﬁrst changes in electroencephalographic activity (appearance of β, θ, or δ rhythms) | 0 min after induction, up to 10 min | 
| electroencephalographic changes | the occurrence of burst suppressions | 0 min after induction, up to 10 min | 
| electroencephalographic changes | duration of suppression period, i.e. the sum of the EEG silences. | 0 min after induction, up to 10 min | 
| hemodynamic changes | blood pressure | 1 min before induction | 
| hemodynamic changes | heart rate | 1 min before induction | 
| hemodynamic changes | blood pressure | during induction procedure | 
| hemodynamic changes | heart rate | during induction procedure | 
| hemodynamic changes | blood pressure | 2 min after induciton | 
| hemodynamic changes | heart rate | 2 min after induciton | 
| hemodynamic changes | blood pressure | 4 min after induciton | 
| hemodynamic changes | heart rate | 4 min after induciton | 
| hemodynamic changes | blood pressure | 6 min after induciton | 
| hemodynamic changes | heart rate | 6 min after induciton | 
| hemodynamic changes | blood pressure | 8 min after induciton | 
| hemodynamic changes | heart rate | 8 min after induciton | 
| hemodynamic changes | blood pressure | 10 min after induciton | 
| hemodynamic changes | heart rate | 10 min after induciton | 
| intubation time | from taking of the intubation device to successful intubation | 0 min after intubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sevoflurane, epileptiform EEG, midazolam, dexmedetomidine