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Reversal of General Anesthesia With Methylphenidate

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ken Solt, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02051452
First received: January 28, 2014
Last updated: January 26, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Post Operative Cognitive Dysfunction Emergence From Anesthesia Drug: Methylphenidate Other: Saline Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Basic Science
Official Title: Reversal of General Anesthesia With Intravenous Methylphenidate

Resource links provided by NLM:


Further study details as provided by Ken Solt, Massachusetts General Hospital:

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

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

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 ]

Estimated Enrollment: 55
Study Start Date: November 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylphenidate
Methylphenidate
Drug: Methylphenidate
Other Name: ritalin
Placebo Comparator: placebo
Saline
Other: Saline

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02051452

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

Responsible Party: Ken Solt, Associate Professor of Anesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02051452     History of Changes
Other Study ID Numbers: 2013P001114
Study First Received: January 28, 2014
Last Updated: January 26, 2017

Additional relevant MeSH terms:
Methylphenidate
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

ClinicalTrials.gov processed this record on June 28, 2017