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

Inhalation Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03394430
• Other study ID #: MDZ/DEX
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 1, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2018
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Yu Sun, MD,PhD
• Phone: 0086-136-1189-5542
• Email: dr_sunyu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: February 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Inhalation Anesthesia

Intervention

Drug:
• Placebos
Patients in Group A receive intranasal normal saline before anesthesia. Anaesthesia was induced with 8% sevo?urane 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.
• Midazolam
Patients in Group B receive intranasal 0.25mg/kg midazolam before anesthesia. Anaesthesia was induced with 8% sevo?urane 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.
• Dexmedetomidine
Patients in Group C receive intranasal 1µg/kg dexmedetomidine before anesthesia. Anaesthesia was induced with 8% sevo?urane 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.

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine	Shanghai

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 classi?ed 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	electroencephalographic changes	the delay between the start of induction and the ?rst changes in electroencephalographic activity (appearance of ß, ?, or d rhythms)	0 min after induction, up to 10 min
Secondary	electroencephalographic changes	the occurrence of burst suppressions	0 min after induction, up to 10 min
Secondary	electroencephalographic changes	duration of suppression period, i.e. the sum of the EEG silences.	0 min after induction, up to 10 min
Secondary	hemodynamic changes	blood pressure	1 min before induction
Secondary	hemodynamic changes	heart rate	1 min before induction
Secondary	hemodynamic changes	blood pressure	during induction procedure
Secondary	hemodynamic changes	heart rate	during induction procedure
Secondary	hemodynamic changes	blood pressure	2 min after induciton
Secondary	hemodynamic changes	heart rate	2 min after induciton
Secondary	hemodynamic changes	blood pressure	4 min after induciton
Secondary	hemodynamic changes	heart rate	4 min after induciton
Secondary	hemodynamic changes	blood pressure	6 min after induciton
Secondary	hemodynamic changes	heart rate	6 min after induciton
Secondary	hemodynamic changes	blood pressure	8 min after induciton
Secondary	hemodynamic changes	heart rate	8 min after induciton
Secondary	hemodynamic changes	blood pressure	10 min after induciton
Secondary	hemodynamic changes	heart rate	10 min after induciton
Secondary	intubation time	from taking of the intubation device to successful intubation	0 min after intubation