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Reversal of General Anesthesia With Methylphenidate

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ClinicalTrials.gov Identifier: NCT02051452
Recruitment Status : Enrolling by invitation
First Posted : January 31, 2014
Last Update Posted : August 7, 2017
Information provided by (Responsible Party):
Ken Solt, Massachusetts General Hospital

Brief Summary:
The aim of this study is to investigate whether methylphenidate (Ritalin) can actively induce emergence from general anesthesia in patients having a pancreaticoduodenectomy (Whipple procedure), a pancreatectomy, or a prostatectomy.

Condition or disease Intervention/treatment Phase
Post Operative Cognitive Dysfunction Emergence From Anesthesia Drug: Methylphenidate Other: Saline Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Reversal of General Anesthesia With Intravenous Methylphenidate
Study Start Date : November 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Methylphenidate
Drug: Methylphenidate
Other Name: ritalin
Placebo Comparator: placebo
Other: Saline

Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Time to emergence from general anesthesia [ Time Frame: 1-4 hours ]

Other Outcome Measures:
  1. Post operative cognitive function at ½ hour, 1 hour and 4 hours after emergence as measured by the Mini Mental Status Exam. [ Time Frame: up to 4 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-75 years
  • American Society of Anesthesiologists classification 1 or 2
  • Scheduled to undergo a pancreaticoduodenectomy or distal pancreatectomy at Massachusetts General Hospital

Exclusion Criteria:

  • American Society of Anesthesiologists physical status classification of 3 or beyond.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051452

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital

Responsible Party: Ken Solt, Associate Professor of Anesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02051452     History of Changes
Other Study ID Numbers: 2013P001114
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents