Phase 4
N=22
Effect of Dexmedetomidine of Gastrointestinal Motility
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT04798482 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Intra-anal Sphincter Pressure (IASP) 1 Minute After Dexmedetomidine Administration — 62.9 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexmedetomidine (Drug)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intra-anal Sphincter Pressure (IASP) 1 Minute After Dexmedetomidine Administration |
62.9 | — |
| PRIMARY Intra-anal Sphincter Pressure (IASP) 5 Minutes After Dexmedetomidine Administration |
45.1 | — |
| PRIMARY Intra-anal Sphincter Pressure (IASP) Baseline Measurement |
80.5 | — |
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 can be psychologically challenging to parents and their child, as it is traditionally performed without adjuvant sedation or anesthesia. Sedatives and anesthesia can alter motility and smooth muscle activity, as well as render it difficult or impossible for the child to follow commands required of the study. Patient or parent non-compliance, inability to follow commands or to tolerate the procedure often renders the study invalid or impossible to complete. Dexmedetomidine is a sedative who's effect on anorectal musculature has not been studied nor determined. It would be important to determine whether it spares smooth muscle function, as it would provide a viable option to provide sedation to children while still preserving their ability to respond to command. The primary objective of this study is to examine the effects of dexmedetomidine on gastrointestinal smooth muscle by observing changes in anorectal manometry before and after dexmedetomdine administration.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT04798482). 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.