CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 22 enrolled
Drug / intervention
Dexmedetomidinedrug
Likely dose
Dexmedetomidine 0.5 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04798482
NCT04798482Phase 4Completed

Effect of Dexmedetomidine of Gastrointestinal Motility

Boston Children's Hospital·interventional·Posted Mar 15, 2021·Updated Apr 26, 2024

In Brief

A Phase 4 clinical trial evaluating Dexmedetomidine for Anesthesia. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedMar 15, 2021
Enrollment StartSep 14, 2021
Primary CompletionNov 15, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.3 years ago

Interventions

Dexmedetomidinedrug

Patients will undergo the usual anal manometry study, with no adjuvant medications, per routine practice currently in the gastrointestinal unit. Following completion of manometry, 0.5 mcg/kg DEX will be administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Manometry measurements will be followed for 15 minutes in response to DEX.