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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03610282
Other study ID # 2018P001421
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date November 2019
Est. completion date November 2021

Study information

Verified date February 2020
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 2021
Est. primary completion date November 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IV Methylphenidate
Subjects will receive a bolus of IV methylphenidate during propofol infusion at one of the study visits.
Propofol
Subjects will received propofol for up to 100 minutes.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

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