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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03394430
Enrollment
45
Registered
2018-01-09
Start date
2018-10-01
Completion date
2019-02-01
Last updated
2018-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inhalation Anesthesia

Keywords

sevoflurane, epileptiform EEG, midazolam, dexmedetomidine

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.

Interventions

DRUGPlacebos

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.

DRUGMidazolam

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.

DRUGDexmedetomidine

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.

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of epileptiform EEG0 min after induction, up to 10 minEEG 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

MeasureTime frameDescription
electroencephalographic changes0 min after induction, up to 10 minthe delay between the start of induction and the first changes in electroencephalographic activity (appearance of β, θ, or δ rhythms)
hemodynamic changes1 min before inductionblood pressure
intubation time0 min after intubationfrom taking of the intubation device to successful intubation

Countries

China

Contacts

Primary ContactYu Sun, MD,PhD
dr_sunyu@163.com0086-136-1189-5542
Backup ContactChenyu Jin
jinchenyu8@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026