Clinical trial NCT03394430: Comparison of Midazolam or Dexmedetomidine on Epileptiform EEG During Sevoflurane Mask Induction
Official title: Comparison of Intranasal Midazolam or Dexmedetomidine on Epileptiform EEG During Sevoflurane Mask Induction in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Inhalation Anesthesia
Keywords: sevoflurane
epileptiform EEG
midazolam
dexmedetomidine
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: incidence of epileptiform EEG
timeFrame: 0 min after induction, up to 10 min
Secondary outcomes:
measure: electroencephalographic changes
timeFrame: 0 min after induction, up to 10 min
measure: electroencephalographic changes
timeFrame: 0 min after induction, up to 10 min
measure: electroencephalographic changes
timeFrame: 0 min after induction, up to 10 min
measure: hemodynamic changes
timeFrame: 1 min before induction
measure: hemodynamic changes
timeFrame: 1 min before induction
measure: hemodynamic changes
timeFrame: during induction procedure
measure: hemodynamic changes
timeFrame: during induction procedure
measure: hemodynamic changes
timeFrame: 2 min after induciton
measure: hemodynamic changes
timeFrame: 2 min after induciton
measure: hemodynamic changes
timeFrame: 4 min after induciton
measure: hemodynamic changes
timeFrame: 4 min after induciton
measure: hemodynamic changes
timeFrame: 6 min after induciton
measure: hemodynamic changes
timeFrame: 6 min after induciton
measure: hemodynamic changes
timeFrame: 8 min after induciton
measure: hemodynamic changes
timeFrame: 8 min after induciton
measure: hemodynamic changes
timeFrame: 10 min after induciton
measure: hemodynamic changes
timeFrame: 10 min after induciton
measure: intubation time
timeFrame: 0 min after intubation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine
Study officials:
References: