EEG Study of IV Methylphenidate-Induced Emergence From Propofol Sedation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2021-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

EEG Studies of IV Methylphenidate-Induced Emergence From Anesthesia

NCT02429076

Active Emergence From General Anesthesia

WITHDRAWN PHASE1/PHASE2

EEG Studies of Ketamine General Anesthesia

NCT03553758

Anesthesia

COMPLETED PHASE2/PHASE3

Ketamine and Propofol NeuroImaging

NCT07294092

Anesthesia Pain

RECRUITING EARLY_PHASE1

Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation

NCT07221539

Mental Function

RECRUITING NA

The Effect on Cognition of Terminating ECT Induced Seizures With Propofol

NCT00616759

Major Depression

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EEG Dynamics

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

Group Type EXPERIMENTAL

IV Methylphenidate

Intervention Type DRUG

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

Propofol

Intervention Type DRUG

Subjects will received propofol for up to 100 minutes.

Propofol EEG Dynamics

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

Group Type PLACEBO_COMPARATOR

Propofol

Intervention Type DRUG

Subjects will received propofol for up to 100 minutes.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IV Methylphenidate

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

Intervention Type DRUG

Propofol

Subjects will received propofol for up to 100 minutes.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ritalin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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