Clinical trial NCT01793753: Effect of Propofol on Internal Anal Sphincter Pressure During ARM
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Constipation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronically constipated children ages 2-6 years who will receive anesthesia for anorectal manometry including propofol per standard of care

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in internal anal sphincter pressure from baseline
timeFrame: Patients will be followed for the duration of outpatient anal rectal manometry procedure, an average of 10 minutes
measure: Time for internal anal sphincter pressure to return to baseline
timeFrame: Patients will be followed for the duration of outpatient anal rectal manometry procedure, an average of 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Jaime Belkind-Gerson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tran K, Kuo B, Zibaitis A, Bhattacharya S, Cote C, Belkind-Gerson J. Effect of propofol on anal sphincter pressure during anorectal manometry. J Pediatr Gastroenterol Nutr. 2014 Apr;58(4):495-7. doi: 10.1097/MPG.0000000000000190.