EEG Study of IV Methylphenidate-Induced Emergence From Propofol Sedation

Anesthesia Clinical Trial

Official title:

Electroencephalogram Study of Intravenous Methylphenidate-Induced Emergence From Propofol Sedation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03610282
• Other study ID #: 2018P001421
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Anesthesia

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