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Trial record 37 of 439 for:    Methylphenidate

Reversal of General Anesthesia With Methylphenidate

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ClinicalTrials.gov Identifier: NCT02051452
Recruitment Status : Completed
First Posted : January 31, 2014
Results First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 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
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methylphenidate
Methylphenidate
Drug: Methylphenidate
Other Name: ritalin

Placebo Comparator: placebo
Saline
Other: Saline



Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 12 months ]
    Recorded as a measure of safety and tolerability


Secondary Outcome Measures :
  1. Time to Emergence From General Anesthesia [ Time Frame: 1-4 hours ]
    Measured as the time from drug (MPH or saline placebo) administration to extubation


Other Outcome Measures:
  1. Post Operative Cognitive Function at ½ Hour, 1 Hour and 2 Hours After Emergence as Measured by the Mini Mental Status Exam. [ Time Frame: up to 4 hours ]
    Return to baseline Mini Mental Status Exam (MMSE) score after general anesthesia, measured at 30, 60, and 120 minutes following extubation. Testing is discontinued when the patient returns to their baseline pre-surgery MMSE score. A faster return to baseline represents a better outcome.



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

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


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Ken Solt, Massachusetts General Hospital:

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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
Results First Posted: August 22, 2019
Last Update Posted: August 22, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Methylphenidate
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Physiological Effects of Drugs
Central Nervous System Stimulants
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents