N/A
Completed N=48
Should Chronic Stimulant Medications be Continued Preoperatively in Patients With Attention Deficit Hyperactivity Disorder(ADHD)
Source: ClinicalTrials.gov NCT01740206 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Heart Rate — 96.7; 88 BPM
Summary
Patients on chronic stimulant therapy for the treatment of Attention deficit hyperactivity disorder (ADHD) who are undergoing an outpatient surgical or diagnostic procedure will be randomized to one of two groups: stimulant medication administered on the day of surgery or stimulant medication withheld on the day of surgery. The choice of anesthetic pharmacology will be at the discretion of the attending anesthesiologist, but the endpoint will be a bispectral index (BIS) between 40 and 60 to ensure adequate and similar depth of anesthesia. Blood pressure, heart rate and use of vasopressors or anticholinergics will be recorded and the incidence of hypotension, bradycardia, or administration of medications will be compared between the two groups.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heart Rate |
96.7; 88 | — |
| SECONDARY Systolic Blood Pressure |
113.6; 109.2 | — |
| SECONDARY Diastolic Blood Pressure |
71.1; 67.9 | — |
| SECONDARY Mean Blood Pressure |
85.3; 81.7 | — |
| SECONDARY mYPAS Measurement in Patients Receiving Midazolam |
30; 26 | — |
| SECONDARY mYPAS Measurement in Patients Not Receiving Midazolam |
28; 28 | — |
Eligibility Criteria
Inclusion Criteria
- Patients will be enrolled if they have been diagnosed with ADHD and have been taking amphetamines and/or methylphenidate for at least the last six months and are undergoing an outpatient surgical or diagnostic procedure.
Exclusion Criteria
- Patients will be excluded if they are taking antidepressant medications, anxiolytic medication, analgesia medications other than acetaminophen or NSAIDs, if they have an allergy to midazolam, or a have cardiac disease.
- Procedures that entail the likelihood of blood transfusion will be excluded.
Data sourced from ClinicalTrials.gov (NCT01740206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.