EEG Study of IV Methylphenidate-Induced Emergence From Propofol Sedation

Electroencephalogram Study of Intravenous Methylphenidate-Induced Emergence From Propofol Sedation

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03610282

Enrollment

Registered

2018-08-01

Start date

2019-11-30

Completion date

2021-11-30

Last updated

2020-02-21

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

Conditions

Anesthesia

Keywords

Propofol, Methylphenidate, Ritalin, Anesthetics, Anesthetics, Intravenous, Molecular Mechanisms of Pharmacological Action, Anesthetics, General, Neurotransmitter Agents, Physiological Effects of Drugs

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.

Interventions

DRUGIV Methylphenidate

Subjects will receive a bolus of IV methylphenidate during propofol infusion at one of the study visits.

DRUGPropofol

Subjects will received propofol for up to 100 minutes.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in multitaper spectral estimates of EEG power during a continuous infusion of propofol.	Up to 100 minutes	Change from baseline in multitaper spectral estimates of EEG power associated with the administration of IV methylphenidate.

Countries

United States

Outcome results

None listed

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