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Clinical Trials/NCT02429076
NCT02429076
Withdrawn
Phase 1

Electroencephalogram Studies of Intravenous Methylphenidate-Induced Emergence From General Anesthesia

Overview

Phase
Phase 1
Intervention
IV methylphenidate
Conditions
Active Emergence From General Anesthesia
Sponsor
Massachusetts General Hospital
Primary Endpoint
Response to methlyphenidate administration
Status
Withdrawn
Last Updated
8 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2017
End Date
December 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ken Solt

Assistant Professor

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Age 18-36 years
  • ASA classification 1 or 2
  • Normal body weight, BMI ≤ 30
  • Right handed
  • 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.

Arms & Interventions

Propofol

Subjects in this arm will receive propofol general anesthesia

Intervention: IV methylphenidate

Propofol

Subjects in this arm will receive propofol general anesthesia

Intervention: Placebo

Propofol

Subjects in this arm will receive propofol general anesthesia

Intervention: Propofol

Sevoflurane

Subjects in this arm will receive sevoflurane general anesthesia

Intervention: IV methylphenidate

Sevoflurane

Subjects in this arm will receive sevoflurane general anesthesia

Intervention: Placebo

Sevoflurane

Subjects in this arm will receive sevoflurane general anesthesia

Intervention: Sevoflurane

Outcomes

Primary Outcomes

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

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