Trial Outcomes & Findings for Reversal of General Anesthesia With Methylphenidate (NCT NCT02051452)
NCT ID: NCT02051452
Last Updated: 2019-08-22
Results Overview
Recorded as a measure of safety and tolerability
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
12 months
Results posted on
2019-08-22
Participant Flow
Participant milestones
| Measure |
Methylphenidate
Patients will receive IV methylphenidate following general anesthesia
|
Placebo
Patients will receive IV saline following general anesthesia
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reversal of General Anesthesia With Methylphenidate
Baseline characteristics by cohort
| Measure |
Methylphenidate
n=16 Participants
Patients will receive IV methylphenidate following general anesthesia
|
Placebo
n=16 Participants
Patients will receive IV saline following general anesthesia
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsRecorded as a measure of safety and tolerability
Outcome measures
| Measure |
Methylphenidate
n=16 Participants
Patients will receive IV methylphenidate following general anesthesia
|
Placebo
n=16 Participants
Patients will receive IV saline following general anesthesia
|
|---|---|---|
|
Number of Participants With Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1-4 hoursMeasured as the time from drug (MPH or saline placebo) administration to extubation
Outcome measures
| Measure |
Methylphenidate
n=16 Participants
Patients will receive IV methylphenidate following general anesthesia
|
Placebo
n=16 Participants
Patients will receive IV saline following general anesthesia
|
|---|---|---|
|
Time to Emergence From General Anesthesia
|
7.5 minutes
Standard Deviation 3.06
|
8.73 minutes
Standard Deviation 3.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 4 hoursReturn 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.
Outcome measures
| Measure |
Methylphenidate
n=16 Participants
Patients will receive IV methylphenidate following general anesthesia
|
Placebo
n=16 Participants
Patients will receive IV saline following general anesthesia
|
|---|---|---|
|
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 after 30 min
|
11 Participants
|
8 Participants
|
|
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 after 60 min
|
4 Participants
|
5 Participants
|
|
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 after 120 min
|
1 Participants
|
3 Participants
|
Adverse Events
Methylphenidate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ken Solt, MD, Associate Professor of Anaesthesia
Harvard Medical School
Phone: 6177264359
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place