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EEG Study of IV Methylphenidate-Induced Emergence From Propofol Sedation

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ClinicalTrials.gov Identifier: NCT03610282
Recruitment Status : Not yet recruiting
First Posted : August 1, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Ken Solt, 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).

Condition or disease Intervention/treatment Phase
Anesthesia Drug: IV Methylphenidate Drug: Propofol Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Electroencephalogram Study of Intravenous Methylphenidate-Induced Emergence From Propofol Sedation
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EEG Dynamics
EEG data will be collected on patients receiving propofol and IV methylphenidate together.
Drug: IV Methylphenidate
Subjects will receive a bolus of IV methylphenidate during propofol infusion at one of the study visits.
Other Name: Ritalin

Drug: Propofol
Subjects will received propofol for up to 100 minutes.

Placebo Comparator: Propofol EEG Dynamics
EEG data will be collected on patients receiving propofol and a saline placebo.
Drug: Propofol
Subjects will received propofol for up to 100 minutes.




Primary Outcome Measures :
  1. Change in multitaper spectral estimates of EEG power during a continuous infusion of propofol. [ Time Frame: Up to 100 minutes ]
    Change from baseline in multitaper spectral estimates of EEG power associated with the administration of IV methylphenidate.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610282


Contacts
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Contact: Edlyn Zhang 617-726-3540 erzhang@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Ken Solt, MD Massachusetts General Hospital

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Responsible Party: Ken Solt, MD, Associate Professor of Anaesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03610282     History of Changes
Other Study ID Numbers: 2018P001421
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ken Solt, Massachusetts General Hospital:
Propofol
Methylphenidate
Ritalin
Anesthetics
Anesthetics, Intravenous
Molecular Mechanisms of Pharmacological Action
Anesthetics, General
Neurotransmitter Agents
Physiological Effects of Drugs
Additional relevant MeSH terms:
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Propofol
Anesthetics
Methylphenidate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Stimulants
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents