NCT02429076

Brief Summary

The aim of this study is to test the hypothesis that methylphenidate actively induces emergence from propofol and sevoflurane general anesthesia in healthy volunteers.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2017

Typical duration for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
2.1 years until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 2, 2017

Status Verified

August 1, 2017

Enrollment Period

2.1 years

First QC Date

April 8, 2015

Last Update Submit

August 1, 2017

Conditions

Active Emergence From General Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Response to methlyphenidate administration

    The number of minutes from the administration of methylphenidate until subjects respond to verbal commands

    minutes to response, expected average is less than 10 minutes

Study Arms (2)

Propofol

EXPERIMENTAL

Subjects in this arm will receive propofol general anesthesia

Drug: IV methylphenidateDrug: PlaceboDrug: Propofol

Sevoflurane

EXPERIMENTAL

Subjects in this arm will receive sevoflurane general anesthesia

Drug: IV methylphenidateDrug: PlaceboDrug: Sevoflurane

Interventions

IV methylphenidateDRUG

IV methylphenidate will be administered to induce emergence from general anesthesia.

PropofolSevoflurane
PlaceboDRUG

normal saline

PropofolSevoflurane
SevofluraneDRUG

Inhaled anesthetic

Sevoflurane
PropofolDRUG

IV anesthetic

Propofol

Eligibility Criteria

Age18 Years - 36 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-36 years
  • ASA classification 1 or 2
  • Normal body weight, BMI ≤ 30
  • Non-smoker
  • Right handed
  • No history of taking stimulants

You may not qualify if:

  • In general, patients will be excluded from the study if the state of their chronic health problems gives them an ASA physical status classification of 3 or beyond.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

MethylphenidateSevofluranePropofol

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 29, 2015

Study Start

June 1, 2017

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

August 2, 2017

Record last verified: 2017-08