Trial Outcomes & Findings for General Anesthesia Emergence Induced by Methylphenidate (NCT NCT02327195)
NCT ID: NCT02327195
Last Updated: 2022-07-12
Results Overview
After stopping isoflurane infusion, when the patient breathes spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
From the moment when isoflurane infusion is stopped until time of extubation
Results posted on
2022-07-12
Participant Flow
Participant milestones
| Measure |
Methylphenidate
Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery
Methylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)
|
Placebo
20 mg Placebo (PO) given 2 hours prior to surgery
Placebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Methylphenidate
n=27 Participants
Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery
Methylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)
|
Placebo
n=27 Participants
20 mg Placebo (PO) given 2 hours prior to surgery
Placebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=54 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=27 Participants
|
27 Participants
n=27 Participants
|
54 Participants
n=54 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=54 Participants
|
|
Age, Continuous
|
32 years
n=27 Participants
|
36 years
n=27 Participants
|
35 years
n=54 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=27 Participants
|
18 Participants
n=27 Participants
|
35 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=27 Participants
|
9 Participants
n=27 Participants
|
19 Participants
n=54 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
27 Participants
n=27 Participants
|
27 Participants
n=27 Participants
|
54 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: From the moment when isoflurane infusion is stopped until time of extubationAfter stopping isoflurane infusion, when the patient breathes spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded.
Outcome measures
| Measure |
Methylphenidate
n=27 Participants
Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery
Methylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)
|
Placebo
n=27 Participants
20 mg Placebo (PO) given 2 hours prior to surgery
Placebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery
|
|---|---|---|
|
Emergence Time
|
9 minutes
Interval 5.0 to 13.0
|
9 minutes
Interval 5.0 to 17.0
|
SECONDARY outcome
Timeframe: First 24 Hours PostoperativelyEfficacy of methylphenidate in preventing post operative nausea and vomiting (PONV) by limited opioids consumption: PONV verbal response scale on a 0 to 10 verbally elicited scale: 0 (no nausea) to 10 (nausea as bad as it could be)
Outcome measures
| Measure |
Methylphenidate
n=27 Participants
Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery
Methylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)
|
Placebo
n=27 Participants
20 mg Placebo (PO) given 2 hours prior to surgery
Placebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery
|
|---|---|---|
|
Number of Participants That Experienced Postoperative Nausea and Vomiting
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During the length of hospital stay post surgery (on average 24 hours), and up to 3 days after surgeryAssess the efficacy of methylphenidate in preventing opioids dose escalation (fast cognitive improvement with efficient pain control -Postoperative Pain Numeric Rating Scale: O=None; (1-3)=Mild; (4-6)= Moderate; (7-10)=Severe).
Outcome measures
| Measure |
Methylphenidate
n=27 Participants
Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery
Methylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)
|
Placebo
n=27 Participants
20 mg Placebo (PO) given 2 hours prior to surgery
Placebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery
|
|---|---|---|
|
Opioid Dose Escalation Prevention
|
1.9 Morphine Milligram Equivalents (MME)
Standard Deviation 4.6
|
2.8 Morphine Milligram Equivalents (MME)
Standard Deviation 5.3
|
Adverse Events
Methylphenidate
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methylphenidate
n=27 participants at risk
Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery
Methylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)
|
Placebo
n=27 participants at risk
20 mg Placebo (PO) given 2 hours prior to surgery
Placebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery
|
|---|---|---|
|
Cardiac disorders
Mild QTc prolongation
|
40.7%
11/27 • Number of events 11 • 34 days
Continued multi-modal monitoring and vigilance with regard to any suspected adverse effects, including cardiovascular effects will help to fill the informational gap with regards to unknown cardiovascular side effects, emergence delirium incidence and perioperatory awareness.Due to the potential risk of drug related serious side effects, any clinical evidence of a serious adverse event will place the study on clinical hold until a full assessment and decision is made by the responsible parties.
|
40.7%
11/27 • Number of events 11 • 34 days
Continued multi-modal monitoring and vigilance with regard to any suspected adverse effects, including cardiovascular effects will help to fill the informational gap with regards to unknown cardiovascular side effects, emergence delirium incidence and perioperatory awareness.Due to the potential risk of drug related serious side effects, any clinical evidence of a serious adverse event will place the study on clinical hold until a full assessment and decision is made by the responsible parties.
|
Other adverse events
Adverse event data not reported
Additional Information
Nicoleta Stoicea
The Ohio State University Wexner Medical Center
Phone: 614-293-3559
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place