The use of simultaneous EEG and fMRI to monitor the effects of ketamine and midazolam on brain activity in healthy adult males
This randomised controlled trial (n=30) evaluated the safety and efficacy of ketamine for healthy volunteers: anaesthetic sedation using 18mg/70kg ketamine.
Detailed Description
EEG and fMRI are two of the principal techniques currently used to measure human brain function. However, EEG and fMRI measure different aspects of brain activity and it is unclear how the measures relate to each other. Both these techniques have the potential to provide important information in understanding how central nervous system medicines alter brain function. However, the results of previous drug studies where these two techniques are
recorded separately are difficult to reconcile. While technically challenging it is now possible to simultaneously record EEG/fMRI. Recording simultaneous EEG/fMRI in the context of drug studies may help to resolve issues raised by previous studies. In this project we propose to record simultaneous EEG/fMRI in healthy volunteer participants while they are given two commonly used anaesthetic drugs, midazolam and ketamine. Our study aims to reconcile previous results in the literature and provide a template example for how future drug imaging studies (involving patients and new medications) might be conducted.
Study Arms & Interventions
Experimental Arm
experimentalInterventions
- Ketamine
- Midalozam
Participants
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 Details
- StatusCompleted
- Typeinterventional
- DesignRandomized
- Target Enrollment30 participants
- TimelineStart: 2016-03-24End: 2016-08-30
- Compounds
- Topic