Reversal of General Anesthesia With Methylphenidate

Phase 1

Completed

• Conditions: Post Operative Cognitive Dysfunction; Emergence From Anesthesia
• Interventions: Other: Saline; Drug: Methylphenidate

• Registration Number: NCT02051452
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-31
• Study Start: 2014-11
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Results First Submitted: 2019-04-25
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-21
• Last Update Submitted: 2019-08-21
• Results First Posted: 2019-08-22
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Saline	Saline
Methylphenidate	Methylphenidate	Methylphenidate

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	12 months	Recorded as a measure of safety and tolerability

Secondary Outcome Measures

Name	Time	Method
Time to Emergence From General Anesthesia	1-4 hours	Measured as the time from drug (MPH or saline placebo) administration to extubation

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States