Emergence From Anesthesia, Post Operative Cognitive Dysfunction
Conditions
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.
Interventions
DRUGMethylphenidate
OTHERSaline
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 12 months | Recorded as a measure of safety and tolerability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Emergence From General Anesthesia | 1-4 hours | Measured as the time from drug (MPH or saline placebo) administration to extubation |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methylphenidate Patients will receive IV methylphenidate following general anesthesia | 16 |
| Placebo Patients will receive IV saline following general anesthesia | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Methylphenidate | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 9 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 7 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 16 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 16 Participants | 32 Participants |
| Region of Enrollment United States | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Number of Participants With Adverse Events
Recorded as a measure of safety and tolerability
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methylphenidate | Number of Participants With Adverse Events | 0 Participants |
| Placebo | Number of Participants With Adverse Events | 0 Participants |
Secondary
Time to Emergence From General Anesthesia
Measured as the time from drug (MPH or saline placebo) administration to extubation
Time frame: 1-4 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methylphenidate | Time to Emergence From General Anesthesia | 7.5 minutes | Standard Deviation 3.06 |
| Placebo | Time to Emergence From General Anesthesia | 8.73 minutes | Standard Deviation 3.5 |
Other Pre-specified
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.
Time frame: up to 4 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Methylphenidate | 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 |
| Methylphenidate | 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 |
| Methylphenidate | 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 |
| Placebo | 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 | 8 Participants |
| Placebo | 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 | 5 Participants |
| Placebo | 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 | 3 Participants |