Back to resultsReversal of General Anesthesia With Methylphenidate
Primary Purpose
Post Operative Cognitive Dysfunction, Emergence From Anesthesia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate
Saline
Sponsored by
About this trial
This is an interventional basic science trial for Post Operative Cognitive Dysfunction
Eligibility 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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Methylphenidate
placebo
Arm Description
Methylphenidate
Saline
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Recorded as a measure of safety and tolerability
Secondary Outcome Measures
Time to Emergence From General Anesthesia
Measured as the time from drug (MPH or saline placebo) administration to extubation
Full Information
NCT ID
NCT02051452
First Posted
January 28, 2014
Last Updated
August 21, 2019
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02051452
Brief Title
Reversal of General Anesthesia With Methylphenidate
Official Title
Reversal of General Anesthesia With Intravenous Methylphenidate
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Cognitive Dysfunction, Emergence From Anesthesia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylphenidate
Arm Type
Experimental
Arm Description
Methylphenidate
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Other Intervention Name(s)
ritalin
Intervention Type
Other
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Recorded as a measure of safety and tolerability
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Time to Emergence From General Anesthesia
Description
Measured as the time from drug (MPH or saline placebo) administration to extubation
Time Frame
1-4 hours
Other Pre-specified Outcome Measures:
Title
Post Operative Cognitive Function at ½ Hour, 1 Hour and 2 Hours After Emergence as Measured by the Mini Mental Status Exam.
Description
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.
Time Frame
up to 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
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Reversal of General Anesthesia With Methylphenidate
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