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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03394430
Recruitment Status : Unknown
Verified February 2018 by Yu Sun, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Recruitment status was:  Not yet recruiting
First Posted : January 9, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Yu Sun, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Inhalation Anesthesia Drug: Placebos Drug: Midazolam Drug: Dexmedetomidine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Intranasal Midazolam or Dexmedetomidine on Epileptiform EEG During Sevoflurane Mask Induction in Children
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Group A Drug: Placebos
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.
Experimental: Group B Drug: Midazolam
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.
Experimental: Group C Drug: Dexmedetomidine
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.


Outcome Measures
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Primary Outcome Measures :
  1. incidence of epileptiform EEG [ Time Frame: 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 :
  1. electroencephalographic changes [ Time Frame: 0 min after induction, up to 10 min ]
    the delay between the start of induction and the first changes in electroencephalographic activity (appearance of β, θ, or δ rhythms)

  2. electroencephalographic changes [ Time Frame: 0 min after induction, up to 10 min ]
    the occurrence of burst suppressions

  3. electroencephalographic changes [ Time Frame: 0 min after induction, up to 10 min ]
    duration of suppression period, i.e. the sum of the EEG silences.

  4. hemodynamic changes [ Time Frame: 1 min before induction ]
    blood pressure

  5. hemodynamic changes [ Time Frame: 1 min before induction ]
    heart rate

  6. hemodynamic changes [ Time Frame: during induction procedure ]
    blood pressure

  7. hemodynamic changes [ Time Frame: during induction procedure ]
    heart rate

  8. hemodynamic changes [ Time Frame: 2 min after induciton ]
    blood pressure

  9. hemodynamic changes [ Time Frame: 2 min after induciton ]
    heart rate

  10. hemodynamic changes [ Time Frame: 4 min after induciton ]
    blood pressure

  11. hemodynamic changes [ Time Frame: 4 min after induciton ]
    heart rate

  12. hemodynamic changes [ Time Frame: 6 min after induciton ]
    blood pressure

  13. hemodynamic changes [ Time Frame: 6 min after induciton ]
    heart rate

  14. hemodynamic changes [ Time Frame: 8 min after induciton ]
    blood pressure

  15. hemodynamic changes [ Time Frame: 8 min after induciton ]
    heart rate

  16. hemodynamic changes [ Time Frame: 10 min after induciton ]
    blood pressure

  17. hemodynamic changes [ Time Frame: 10 min after induciton ]
    heart rate

  18. intubation time [ Time Frame: 0 min after intubation ]
    from taking of the intubation device to successful intubation


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394430


Contacts
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Contact: Yu Sun, MD,PhD 0086-136-1189-5542 dr_sunyu@163.com
Contact: Chenyu Jin jinchenyu8@163.com

Locations
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China
Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine
Shanghai, China
Contact: Yu Sun, MD,PhD    0086-136-1189-5542    dr_sunyu@163.com   
Sub-Investigator: Chenyu Jin         
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
More Information
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Responsible Party: Yu Sun, Principal Investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT03394430    
Other Study ID Numbers: MDZ/DEX
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yu Sun, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
sevoflurane
epileptiform EEG
midazolam
dexmedetomidine
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Midazolam
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
 Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents