EEG Study of IV Methylphenidate-Induced Emergence From Pr... | NCT03610282

Studies
EEG Study of IV Methylphenidate-Induced Emergence From Propofol Sedation

NCT03610282

Sponsor

Massachusetts General Hospital

Status

Withdrawn

Last Update Posted

Feb 21, 2020Actual

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Anesthesia

Interventions

IV Methylphenidate
Propofol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

We have decided to withdraw the study prior to enrollment of the first participant in order to pursue other research studies.

Expanded Access Info

Not provided

Start Date

Nov 2019Estimated

Primary Completion Date

Nov 2020Estimated

Completion Date

Nov 2021Estimated

First Submitted Date

Jul 26, 2018

First Submission Date that Met QC Criteria

Jul 26, 2018

First Posted Date

Aug 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2020

Last Update Posted Date

Feb 21, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ken Solt, MD, Associate Professor of Anaesthesia, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
IV Methylphenidate	Drug	Subjects will receive a bolus of IV methylphenidate during propofol infusion at one of the study visits.	EEG Dynamics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ken Solt, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

Intervention Browse Module

MeSH Terms

ID	Term
D008774	Methylphenidate
D015742	Propofol

Ancestor Terms

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

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Browse Branches

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