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: April 8, 2015
Last verified: April 2015
  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).


Condition Intervention Phase
Post Operative Cognitive Dysfunction
Emergence From Anesthesia
Drug: Methylphenidate
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 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylphenidate
Methylphenidate
Drug: Methylphenidate
Other Name: ritalin
Placebo Comparator: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Ken Solt, Assistant 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: April 8, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Methylphenidate
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on June 28, 2015