The use of simultaneous electroencephalography (EEG) and functional magnetic resonance imaging (fMRI) to monitor the effects of ketamine and midazolam on brain activity

Completed

• Conditions: Healthy volunteers: Anaesthetic sedation; Neurological - Studies of the normal brain and nervous system; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12616000281493
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-03
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

*Participant is willing and able to give informed consent for participation in the study
*In the Investigators’ opinion, is able and willing to comply with all study requirements

Exclusion Criteria

*Cardiovascular conditions including abnormal heart rate and blood pressure checked at screening.
*Participants who have participated in another research study involving an investigational product in the past 12 weeks.
*History of psychosis or personality disorder.
*Any unstable medical or neurologic condition.
*Substance abuse or dependence in previous 6 months.
*Any history of abuse of ketamine or benzodiazepenes.
*Contraindication to the use of ketamine/midazolam according to manufacturer guidelines.
*Body-weight <50kg or >120kg.
*BMI <18.5 or > 30
* Failure of the Health Questionnaire section of the Anaesthesia assessment patient questionnaire”.
*Any other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the study.
*Regular use of any medication deemed to be contraindicating as judged by the attending study physicians (e.g. benzodiazepenes / sedatives / sleeping agents / NMDA antagonists).
*Inability to speak or read English.
*Contraindications for MRI scanning
*Needle phobia
*History of claustrophobia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Power spectral density of the EEG[0-10 minutes post administration]

Secondary Outcome Measures

Name	Time	Method
Functional connectivity measured with functional magnetic resonance imaging (fMRI)[0-10 minutes post administration]