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OpenTrials
Completed

NCT Number: NCT02051452

Reversal of General Anesthesia With Methylphenidate

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.

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Key information

Conditions

Post Operative Cognitive Dysfunction Emergence From Anesthesia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methylphenidate

Drug

Other names: ritalin

Saline

Other

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 12 months

    Recorded as a measure of safety and tolerability

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Reversal of General Anesthesia With Intravenous Methylphenidate

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 31, 2014
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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