A Phase 1/2 interventional study of IV Methylphenidate and Propofol in Anesthesia, sponsored by Massachusetts General Hospital. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-21.
Sponsored by Massachusetts General Hospital · Phase 1/2, Interventional, and Basic science
The investigators are performing this research study to find out if intravenous (IV) methylphenidate (commonly known as Ritalin) can help people recover faster from propofol sedation. The investigators also want to know how IV methylphenidate acts in the brain and whether IV methylphenidate is safe to take with an anesthetic (a drug or agent used to decrease or eliminate the feeling of pain by causing unconsciousness) without causing too many side effects. The brain's electrical activity will be studied and recorded using a machine called an electroencephalogram (EEG).
During this research study, participants will receive propofol, and propofol and IV methylphenidate together, at a high enough dose to achieve unconsciousness (make study participants "fall asleep"). During one visit participants will receive propofol and a saline placebo; during another visit participants will be given both propofol and IV methylphenidate together. The investigators will record EEG the entire time, The investigators will also ask some questions related to cognitive function.
Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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EEG data will be collected on patients receiving propofol and IV methylphenidate together.
Drug: IV Methylphenidate · Drug: Propofol
EEG data will be collected on patients receiving propofol and a saline placebo.
Drug: Propofol
Subjects will receive a bolus of IV methylphenidate during propofol infusion at one of the study visits.
Also known as: Ritalin
Subjects will received propofol for up to 100 minutes.
Change in multitaper spectral estimates of EEG power during a continuous infusion of propofol.
Change from baseline in multitaper spectral estimates of EEG power associated with the administration of IV methylphenidate.
Time frame: Up to 100 minutes
This study is withdrawn, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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