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EEG Studies of IV Methylphenidate-Induced Emergence From Anesthesia

Electroencephalogram Studies of Intravenous Methylphenidate-Induced Emergence From General Anesthesia

Status
Withdrawn
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02429076
Enrollment
0
Registered
2015-04-29
Start date
2017-06-30
Completion date
2019-12-31
Last updated
2017-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Emergence From General Anesthesia

Brief summary

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

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.

Interventions

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

DRUGPlacebo

normal saline

DRUGSevoflurane

Inhaled anesthetic

DRUGPropofol

IV anesthetic

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 36 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Response to methlyphenidate administrationminutes to response, expected average is less than 10 minutesThe number of minutes from the administration of methylphenidate until subjects respond to verbal commands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026