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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

Tracking Information
First Submitted Date  ICMJE July 26, 2018
First Posted Date  ICMJE August 1, 2018
Last Update Posted Date March 7, 2019
Estimated Study Start Date  ICMJE November 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03610282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EEG Study of IV Methylphenidate-Induced Emergence From Propofol Sedation
Official Title  ICMJE Electroencephalogram Study of Intravenous Methylphenidate-Induced Emergence From Propofol Sedation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: EEG Dynamics
    EEG data will be collected on patients receiving propofol and IV methylphenidate together.
    Interventions:
    • Drug: IV Methylphenidate
    • Drug: Propofol
  • Placebo Comparator: Propofol EEG Dynamics
    EEG data will be collected on patients receiving propofol and a saline placebo.
    Intervention: Drug: Propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2019)
15
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2018)
12
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Edlyn Zhang 617-726-3540 erzhang@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03610282
Other Study ID Numbers  ICMJE 2018P001421
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ken Solt, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ken Solt, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP