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Effect of Propofol on Internal Anal Sphincter Pressure During ARM

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01793753
Enrollment
20
Registered
2013-02-18
Start date
2012-10-31
Completion date
2013-06-30
Last updated
2016-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Constipation

Brief summary

Background and Aim: An anorectal manometry (ARM) is a common test in the evaluation of outlet obstruction in constipation. In children under 6 yo, anesthesia is often used for patient comfort and compliance. The choice of anesthesia for ARM varies from center to center and includes the use of ketamine, inhalation agents, and propofol. With the increased use of propofol, our aim is to determine the effects of propofol on resting anal sphincter pressure while performing an ARM under general anesthesia. Hypothesis: Propofol administration leads to a decrease in internal anal sphincter pressure. Methods: This is a prospective, single center, observational study of the effect of propofol on the internal anal sphincter pressure. Pediatric patients between the ages of 2-6 years who require an anorectal manometry for chronic constipation will be offered enrollment. Anesthesia was required for patient compliance and comfort and conducted by an anesthesiologist. Sevoflurane was the inhalational agent used for induction. At Massachusetts General Hospital (MGH), 1 mg/kg of propofol bolus is routinely given at completion of the ARM test to reduce emergence delirium. The manometric probe was kept in place with continuous measurement of baseline internal anal sphincter pressure while propofol was administered. We measured changes to internal anal sphincter pressure and time to return to baseline. Results: The primary outcomes will be change of internal anal sphincter pressure from baseline and time to return to baseline. Discussion: The proposed investigation may demonstrate that propofol has an effect on the internal anal sphincter pressure which may affect its utility as an anesthetic for anorectal manometry.

Interventions

DRUGPropofol

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No

Inclusion criteria

* Ages 2 - 6 years * Chronic constipation * Requires anorectal manometry

Exclusion criteria

* Ages 0-2 or \> 6 years * Abnormal anorectal anatomy * Known history of Hirschsprung's Disease

Design outcomes

Primary

MeasureTime frameDescription
Change in internal anal sphincter pressure from baselinePatients will be followed for the duration of outpatient anal rectal manometry procedure, an average of 10 minutesBaseline internal anal sphincter pressures will be measured at start of anorectal manometry. Patients will be followed for the duration of the procedure (\ 10 minutes). After propofol is given at end of procedure, changes to baseline internal anal sphincter pressure will be measured until return to baseline (up to 5 minutes)
Time for internal anal sphincter pressure to return to baselinePatients will be followed for the duration of outpatient anal rectal manometry procedure, an average of 10 minutesPatients will be followed for the duration of the procedure (\ 10 minutes). After propofol is given at end of procedure, changes to baseline internal anal sphincter pressure will be measured until return to baseline (up to 5 minutes)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026