EEG Studies of IV Methylphenidate-Induced Emergence From Anesthesia

Study Overview
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Brief Summary
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The aim of this study is to test the hypothesis that methylphenidate actively induces emergence from propofol and sevoflurane general anesthesia in healthy volunteers.

Detailed Description
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Basic science and clinical data suggest that activation of one or more of the brain's arousal pathways is a highly plausible way to induce active emergence from general anesthesia. The investigators have compelling experimental data demonstrating that methylphenidate is highly effective in actively inducing emergence from isoflurane and propofol general anesthesia in rodents. The available literature suggests that IV methylphenidate would be safe to administer to patients recovering from general anesthesia, and that in addition to promoting arousal, it would enhance breathing. Both of these effects would be highly desirable in patients recovering from general anesthesia.

Official Title
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Electroencephalogram Studies of Intravenous Methylphenidate-Induced Emergence From General Anesthesia

Conditions
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Active Emergence From General Anesthesia

Intervention / Treatment
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* Drug: IV methylphenidate
* Drug: Placebo
* Drug: Sevoflurane
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-36 years ASA classification 1 or 2 Normal body weight, BMI ≤ 30 Non-smoker Right handed No history of taking stimulants Exclusion Criteria: In general, patients will be excluded from the study if the state of their chronic health problems gives them an ASA physical status classification of 3 or beyond.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol<br>Subjects in this arm will receive propofol general anesthesia | Drug: IV methylphenidate<br>* IV methylphenidate will be administered to induce emergence from general anesthesia.<br>Drug: Placebo<br>* normal saline<br>Drug: Propofol<br>* IV anesthetic<br>|
| Experimental: Sevoflurane<br>Subjects in this arm will receive sevoflurane general anesthesia | Drug: IV methylphenidate<br>* IV methylphenidate will be administered to induce emergence from general anesthesia.<br>Drug: Placebo<br>* normal saline<br>Drug: Sevoflurane<br>* Inhaled anesthetic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to methlyphenidate administration | The number of minutes from the administration of methylphenidate until subjects respond to verbal commands | minutes to response, expected average is less than 10 minutes |