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

NCT03394430 | Unknown Phase 4

• 1 other identifier: MDZ/DEX
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Inhalation Anesthesia

Keywords

sevoflurane; epileptiform EEG; midazolam; dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• electroencephalographic changes

  0 min after induction, up to 10 min

• electroencephalographic changes

  0 min after induction, up to 10 min

• electroencephalographic changes

  0 min after induction, up to 10 min

• hemodynamic changes

  1 min before induction

• hemodynamic changes

  1 min before induction

Study Arms (3)

Group A

PLACEBO COMPARATOR

Drug: Placebos

Group B

EXPERIMENTAL

Drug: Midazolam

Group C

EXPERIMENTAL

Drug: Dexmedetomidine

Interventions

Placebos DRUG

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.

Group A

Midazolam DRUG

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.

Group B

Dexmedetomidine DRUG

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.

Group C

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

MeSH Terms

Interventions

Midazolam; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Yu Sun, MD,PhD

CONTACT

0086-136-1189-5542; dr_sunyu@163.com

Chenyu Jin

CONTACT

jinchenyu8@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2017
• First Posted: January 9, 2018
• Study Start: October 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: February 1, 2019
• Last Updated: September 25, 2018

Record last verified: 2018-02

Locations

CN (1)