EEG Study of IV Methylphenidate-Induced Emergence From Propofol Sedation

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03610282

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 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

Anticipated Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Nov 1, 2020

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

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 Names: 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.

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 Names:

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.

Outcome Measures

Primary Outcome Measures

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.