Status:
COMPLETED
Effect of Dexmedetomidine of Gastrointestinal Motility
Lead Sponsor:
Boston Children's Hospital
Conditions:
Anesthesia
Eligibility:
All Genders
3-18 years
Phase:
PHASE4
Brief Summary
Anorectal manometry requires that the patient be able to respond to command and not receive any medications which could alter muscle tone or motility. In the pediatric population, anorectal manometry ...
Detailed Description
Primary objective: To examine the effects of dexmedetomidine on intra-anal pressure and the dose response curve to balloon distention by comparing the baseline measurements with those after dexmedeto...
Eligibility Criteria
Inclusion
- Ages 3-18 years who are scheduled to have an anorectal manometry followed by an upper or lower endoscopic procedures at Boston Children's Hospital
- Patients are cooperative to do the anorectal manometry without sedation (besides pre-med midazolam)
- Anticipates to receive standard sedation with dexmedetomidine and propofol for a gastrointestinal procedure in the Gastroenterology Procedure Unit (GPU)
- Provides written consent to participate in the research study
- In females of reproductive age, pregnancy testing
Exclusion
- Do not meet established sedation criteria
- Patients who require sedation prior to their anal manometry testing
- History of allergy, intolerance, or reaction to dexmedetomidine
- Current, repaired or risk of Moya-Moya disease
- Recent stroke (cerebrovascular accident) within past 6 months
- Uncontrolled hypertension
- Concomitant use of opioids, beta antagonist, alpha 2 agonist or calcium channel blocker
- BMI greater than 30 or weight above 110th percentile
- Refuses insertion of intravenous catheter while awake
- Currently receiving pharmacologic agents for hypertension or cardiac disease
- Currently receiving or has received digoxin within the past 3 months
- Active, uncontrolled gastroesophageal reflux (an aspiration risk), requiring endotracheal intubation.
- Current (or within past 3 months) history of apnea requiring an apnea monitor
- Unstable cardiac status (life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction)
- Craniofacial anomaly, which could make it difficult to effectively establish a mask airway for positive pressure ventilation if needed
- Active, current respiratory issues that are different from the baseline status (pneumonia, exacerbation of asthma, bronchiolitis, respiratory syncytial virus).
Key Trial Info
Start Date :
September 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04798482
Start Date
September 14 2021
End Date
November 15 2022
Last Update
April 26 2024
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115