EEG Studies of IV Methylphenidate-Induced Emergence From Anesthesia

Mass General Brigham

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Active Emergence From General Anesthesia

Treatments: Drug: Sevoflurane; Drug: Placebo; Drug: IV methylphenidate; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT02429076

2015P000566

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18 to 36 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Propofol

Experimental group

Description:

Subjects in this arm will receive propofol general anesthesia

Treatment:

Drug: Placebo

Drug: IV methylphenidate

Drug: Propofol

Sevoflurane

Experimental group

Description:

Subjects in this arm will receive sevoflurane general anesthesia

Treatment:

Drug: Placebo

Drug: IV methylphenidate

Drug: Sevoflurane