Reversal of General Anesthesia With Methylphenidate

Post Operative Cognitive Dysfunction Clinical Trial

Official title:

Reversal of General Anesthesia With Intravenous Methylphenidate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051452
• Other study ID #: 2013P001114
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 2014
• Est. completion date: May 2018

Study information

• Verified date: August 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Emergence From Anesthesia
• Post Operative Cognitive Dysfunction

Intervention

Drug:
• Methylphenidate

Other:
• Saline

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post Operative Cognitive Function at ½ Hour, 1 Hour and 2 Hours After Emergence as Measured by the Mini Mental Status Exam.	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.	up to 4 hours
Primary	Number of Participants With Adverse Events	Recorded as a measure of safety and tolerability	12 months
Secondary	Time to Emergence From General Anesthesia	Measured as the time from drug (MPH or saline placebo) administration to extubation	1-4 hours