EEG Studies of IV Methylphenidate-Induced Emergence From Anesthesia

August 1, 2017 updated by: Ken Solt, Massachusetts General Hospital

Electroencephalogram Studies of Intravenous Methylphenidate-Induced Emergence From General Anesthesia

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Basic science and clinical data suggest that activation of one or more of the brain's arousal pathways is a highly plausible way to induce active emergence from general anesthesia. The investigators have compelling experimental data demonstrating that methylphenidate is highly effective in actively inducing emergence from isoflurane and propofol general anesthesia in rodents. The available literature suggests that IV methylphenidate would be safe to administer to patients recovering from general anesthesia, and that in addition to promoting arousal, it would enhance breathing. Both of these effects would be highly desirable in patients recovering from general anesthesia.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 36 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propofol
Subjects in this arm will receive propofol general anesthesia
Drug: Placebo
normal saline
Drug: IV methylphenidate
IV methylphenidate will be administered to induce emergence from general anesthesia.
Drug: Propofol
IV anesthetic
Experimental: Sevoflurane
Subjects in this arm will receive sevoflurane general anesthesia
Drug: Placebo
normal saline
Drug: IV methylphenidate
IV methylphenidate will be administered to induce emergence from general anesthesia.
Drug: Sevoflurane
Inhaled anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to methlyphenidate administration
Time Frame: minutes to response, expected average is less than 10 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2017

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015P000566

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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