Effect of Dexmedetomidine of Gastrointestinal Motility

NCT04798482 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB-P00035865
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (3)

• Intra-anal Sphincter Pressure (IASP) 1 Minute After Dexmedetomidine Administration

  1 minute

• Intra-anal Sphincter Pressure (IASP) 5 Minutes After Dexmedetomidine Administration

  5 minutes

• Intra-anal Sphincter Pressure (IASP) Baseline Measurement

  IASP recorded prior to administration of dexmedetomidine

  30 seconds

Study Arms (1)

Dexmedetomidine

EXPERIMENTAL

This is a single arm, open label, interventional study examining the effects of dexmedetomidine on anal manometry. All subjects will be administered dexmedetomidine following their baseline manometry measurements. Following dexmedetomidine administration, anal manometry measurements will be observed for 15 minutes.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

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.

Dexmedetomidine

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (22)

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MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Keira Mason MD
• Organization: Boston Children's Hospital

keira.mason@childrens.harvard.edu

617-355-5775

Study Officials

• Keira Mason, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesia, Harvard Medical School Boston Children's Hospital

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: March 15, 2021
• Study Start: September 14, 2021
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: April 26, 2024
• Results First Posted: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)