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Reversal of General Anesthesia With Methylphenidate

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Ken Solt, Massachusetts General Hospital Identifier:
First received: January 28, 2014
Last updated: June 21, 2016
Last verified: June 2016
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) or a distal pancreatectomy.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Reversal of Propofol-Induced General Anesthesia With Intravenous Methylphenidate

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to emergence from general anesthesia [ Time Frame: 1-4 hours ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: November 2014
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylphenidate
Drug: Methylphenidate
Other Name: ritalin
Placebo Comparator: placebo
Other: Saline


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02051452

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

Responsible Party: Ken Solt, Assistant Professor of Anesthesia, Massachusetts General Hospital Identifier: NCT02051452     History of Changes
Other Study ID Numbers: 2013P001114 
Study First Received: January 28, 2014
Last Updated: June 21, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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 processed this record on October 27, 2016