EEG Study of IV Methylphenidate-Induced Emergence From Propofol Sedation

Mass General Brigham

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Anesthesia

Treatments: Drug: IV Methylphenidate; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT03610282

2018P001421

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

0 participants in 2 patient groups, including a placebo group

EEG Dynamics

Experimental group

Description:

EEG data will be collected on patients receiving propofol and IV methylphenidate together.

Treatment:

Drug: IV Methylphenidate

Drug: Propofol

Propofol EEG Dynamics

Placebo Comparator group

Description:

EEG data will be collected on patients receiving propofol and a saline placebo.

Treatment:

Drug: Propofol