EEG Study of IV Methylphenidate-Induced Emergence From Propofol Sedation

NCT03610282 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 2018P001421
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Anesthesia

Keywords

Propofol; Methylphenidate; Ritalin; Anesthetics; Anesthetics, Intravenous; Molecular Mechanisms of Pharmacological Action; Anesthetics, General; Neurotransmitter Agents; Physiological Effects of Drugs

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

EEG Dynamics

EXPERIMENTAL

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

Drug: IV Methylphenidate; Drug: Propofol

Propofol EEG Dynamics

PLACEBO COMPARATOR

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

Drug: Propofol

Interventions

IV Methylphenidate DRUG

Subjects will receive a bolus of IV methylphenidate during propofol infusion at one of the study visits.

Also known as: Ritalin

EEG Dynamics

Propofol DRUG

Subjects will received propofol for up to 100 minutes.

EEG Dynamics; Propofol EEG Dynamics

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Chronic health conditions

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Methylphenidate; Propofol

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Ken Solt, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor of Anaesthesia

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 1, 2018
• Study Start: November 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2021
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

US (1)