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

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.

Study Overview

• Status: Unknown
• Conditions: Inhalation Anesthesia
• Intervention / Treatment: Drug: Placebos; Drug: Midazolam; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yu Sun, MD,PhD; Phone Number: 0086-136-1189-5542; Email: dr_sunyu@163.com
• Study Contact Backup: Name: Chenyu Jin; Email: jinchenyu8@163.com

Study Locations

• China
  • Shanghai, China
    • Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine
    • Contact: Yu Sun, MD,PhD; Phone Number: 0086-136-1189-5542; Email: dr_sunyu@163.com
    • Sub-Investigator: Chenyu Jin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of epileptiform EEG	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.	0 min after induction, up to 10 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
electroencephalographic changes	the delay between the start of induction and the first changes in electroencephalographic activity (appearance of β, θ, or δ rhythms)	0 min after induction, up to 10 min
electroencephalographic changes	the occurrence of burst suppressions	0 min after induction, up to 10 min
electroencephalographic changes	duration of suppression period, i.e. the sum of the EEG silences.	0 min after induction, up to 10 min
hemodynamic changes	blood pressure	1 min before induction
hemodynamic changes	heart rate	1 min before induction
hemodynamic changes	blood pressure	during induction procedure
hemodynamic changes	heart rate	during induction procedure
hemodynamic changes	blood pressure	2 min after induciton
hemodynamic changes	heart rate	2 min after induciton
hemodynamic changes	blood pressure	4 min after induciton
hemodynamic changes	heart rate	4 min after induciton
hemodynamic changes	blood pressure	6 min after induciton
hemodynamic changes	heart rate	6 min after induciton
hemodynamic changes	blood pressure	8 min after induciton
hemodynamic changes	heart rate	8 min after induciton
hemodynamic changes	blood pressure	10 min after induciton
hemodynamic changes	heart rate	10 min after induciton
intubation time	from taking of the intubation device to successful intubation	0 min after intubation

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: December 17, 2017
• First Submitted That Met QC Criteria: January 7, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 23, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: midazolam; sevoflurane; dexmedetomidine; epileptiform EEG
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: MDZ/DEX

Drug and device information, study documents

• 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