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

Phase 4

• Conditions: Inhalation Anesthesia
• Interventions: Drug: Placebos; Drug: Midazolam; Drug: Dexmedetomidine

• Registration Number: NCT03394430
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-17
• Study First Submitted QC: 2018-01-07
• Study First Posted: 2018-01-09
• Status Verified: 2018-02
• Last Update Submitted: 2018-09-23
• Last Update Posted: 2018-09-25
• Study Start: 2018-10-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• ASA physical status 1-2
• Scheduled for general anesthesia

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Placebos	-
Group B	Midazolam	-
Group C	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
incidence of epileptiform EEG	0 min after induction, up to 10 min	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.

Secondary Outcome Measures

Name	Time	Method
intubation time	0 min after intubation	from taking of the intubation device to successful intubation
electroencephalographic changes	0 min after induction, up to 10 min	duration of suppression period, i.e. the sum of the EEG silences.
hemodynamic changes	10 min after induciton	heart rate

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China