Reversal of General Anesthesia With Methylphenidate
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2014
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2014
CompletedFirst Posted
Study publicly available on registry
January 31, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedResults Posted
Study results publicly available
August 22, 2019
CompletedAugust 22, 2019
August 1, 2019
3.5 years
January 28, 2014
April 25, 2019
August 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events
Recorded as a measure of safety and tolerability
12 months
Secondary Outcomes (1)
Time to Emergence From General Anesthesia
1-4 hours
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.
up to 4 hours
Study Arms (2)
Methylphenidate
EXPERIMENTALMethylphenidate
placebo
PLACEBO COMPARATORSaline
Interventions
Eligibility Criteria
You may qualify if:
- Age 18-75 years
- American Society of Anesthesiologists classification 1 or 2
- Scheduled to undergo a pancreaticoduodenectomy or distal pancreatectomy at Massachusetts General Hospital
You may not qualify if:
- American Society of Anesthesiologists physical status classification of 3 or beyond.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ken Solt, MD, Associate Professor of Anaesthesia
- Organization
- Harvard Medical School
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Anesthesia
Study Record Dates
First Submitted
January 28, 2014
First Posted
January 31, 2014
Study Start
November 1, 2014
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
August 22, 2019
Results First Posted
August 22, 2019
Record last verified: 2019-08