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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Inhalation Anesthesia

Treatments: Drug: Midazolam; Drug: Dexmedetomidine; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03394430

MDZ/DEX

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups, including a placebo group

Group A

Placebo Comparator group

Treatment:

Drug: Placebos

Group B

Experimental group

Treatment:

Drug: Midazolam

Group C

Experimental group

Treatment:

Drug: Dexmedetomidine