EEG Study of IV Methylphenidate-Induced Emergence From Propofol Sedation

Study Overview
=================
Brief Summary
-----------------
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).

Detailed Description
-----------------
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.

Official Title
-----------------
Electroencephalogram Study of Intravenous Methylphenidate-Induced Emergence From Propofol Sedation

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: IV Methylphenidate
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18 to 45 Normal body weight and habitus, BMI ≤ 30 Non-smoker No history of taking stimulants American Society of Anesthesiologists (ASA) physical status classification P1 Exclusion Criteria: • Chronic health conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EEG Dynamics<br>EEG data will be collected on patients receiving propofol and IV methylphenidate together. | Drug: IV Methylphenidate<br>* Subjects will receive a bolus of IV methylphenidate during propofol infusion at one of the study visits.<br>* Other names: Ritalin;Drug: Propofol<br>* Subjects will received propofol for up to 100 minutes.<br>|
| Placebo Comparator: Propofol EEG Dynamics<br>EEG data will be collected on patients receiving propofol and a saline placebo. | Drug: Propofol<br>* Subjects will received propofol for up to 100 minutes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 100 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Propofol, Methylphenidate, Ritalin, Anesthetics, Anesthetics, Intravenous, Molecular Mechanisms of Pharmacological Action, Anesthetics, General, Neurotransmitter Agents, Physiological Effects of Drugs