EEG Study of IV Methylphenidate-Induced Emergence From Propofol Sedation

Phase 1

Withdrawn

• Conditions: Anesthesia
• Interventions: Drug: Propofol; Drug: IV Methylphenidate

• Registration Number: NCT03610282
• Lead Sponsor: Massachusetts General Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-08-01
• Study Start: 2019-11
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-21
• Primary Completion: 2020-11
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Chronic health conditions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Propofol EEG Dynamics	Propofol	EEG data will be collected on patients receiving propofol and a saline placebo.
EEG Dynamics	IV Methylphenidate	EEG data will be collected on patients receiving propofol and IV methylphenidate together.
EEG Dynamics	Propofol	EEG data will be collected on patients receiving propofol and IV methylphenidate together.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States