EEG Studies of IV Methylphenidate-Induced Emergence From Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2019-12-31

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.

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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.

Conditions

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Active Emergence From General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Propofol

Subjects in this arm will receive propofol general anesthesia

Group Type EXPERIMENTAL

IV methylphenidate

Intervention Type DRUG

IV methylphenidate will be administered to induce emergence from general anesthesia.

Placebo

Intervention Type DRUG

normal saline

Propofol

Intervention Type DRUG

IV anesthetic

Sevoflurane

Subjects in this arm will receive sevoflurane general anesthesia

Group Type EXPERIMENTAL

IV methylphenidate

Intervention Type DRUG

IV methylphenidate will be administered to induce emergence from general anesthesia.

Placebo

Intervention Type DRUG

normal saline

Sevoflurane

Intervention Type DRUG

Inhaled anesthetic

Interventions

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IV methylphenidate

IV methylphenidate will be administered to induce emergence from general anesthesia.

Intervention Type DRUG

Placebo

normal saline

Intervention Type DRUG

Sevoflurane

Inhaled anesthetic

Intervention Type DRUG

Propofol

IV anesthetic

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age 18-36 years
2. ASA classification 1 or 2
3. Normal body weight, BMI ≤ 30
4. Non-smoker
5. Right handed
6. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes