None listed
Conditions
Brief summary
Both alone and in combination, the effects of Ketamine, Fentanyl and Dexmedetomidine are effective at providing analgesia to patients in the ICU. However, these drug combinations can potentially also have very important consequences for tasks involving complex cognitive and behavioural ability, which includes making important clinical decisions (in a clinical setting both during and post-treatment), and driving a car (post treatment discharge). Currently, it is unclear which clinically indicated drug combination (either KET/DEX or KET/FENT) has more favourable effects on sedation, alertness and cognitive/neurobehavioral outcomes. We therefore seek to test whether sub-anaesthetic KET/DEX combination will yield in better analgesic and alertness level when compared to KET/FENT, and if there are any differences in cognitive and neurobehavioral abilities between these drug conditions.
Interventions
This study will have two distinct treatment arms, where participants will receive either a combination of intravenous ketamine and Fentanyl, or intravenous ketamine and Dexmedetomidine.
In all cases, participants will begin by receiving a bolus dose of 0.3mg/kg intravenous ketamine, to be immediately followed by a ketamine only intravenous infusion of 0.15mg/kg/hr for one hour (total ketamine infusion of three hours for each study arm). After this one-hour ketamine only period, participants wi
This study will have two distinct treatment arms, where participants will receive either a combination of intravenous ketamine and Fentanyl, or intravenous ketamine and Dexmedetomidine. In all cases, participants will begin by receiving a bolus dose of 0.3mg/kg intravenous ketamine, to be immediately followed by a ketamine only intravenous infusion of 0.15mg/kg/hr for one hour (total ketamine infusion of three hours for each study arm). After this one-hour ketamine only period, participants will then receive either: -Receive three 25mcg intravenous injections of Fentanyl at 1.5, 2 and 2.5 hrs after ketamine infusion commencement (if in KET/FENT arm) OR -Receive additional 0.7mcg/kg/hr intravenous infusion of Dexmedetomidine commencing one hour post ketamine-only infusion, for a duration of two hours (if in KET/DEX arm).
Sponsors
Monash Medical Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Aged between 21 and 45 years. Hold a full drivers licence (no ‘P’ plates). No known allergic reaction to ketamine or other related opioids. Have no history of past substance abuse or current abuse of illicit drugs. Have no pre-existing physical or neurological conditions, no previous or current history of severe psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders. Not currently pregnant or lactating
Exclusion criteria
Inability to speak or read English. Taking any form of medication within 5 days of admission (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study. Unable to participate in scheduled visit, treatment plan, tests and other trial procedures according to the protocol. Current participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit.
Outcome results
None listed