Effect of Propofol on Internal Anal Sphincter Pressure During ARM

September 12, 2016 updated by: Jaime Belkind-Gerson, MD, Massachusetts General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Propofol
Chronically constipated children ages 2-6 years who will receive anesthesia for anorectal manometry including propofol per standard of care
Drug: Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in internal anal sphincter pressure from baseline
Time Frame: Patients will be followed for the duration of outpatient anal rectal manometry procedure, an average of 10 minutes
Baseline 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)
Patients will be followed for the duration of outpatient anal rectal manometry procedure, an average of 10 minutes
Time for internal anal sphincter pressure to return to baseline
Time Frame: Patients will be followed for the duration of outpatient anal rectal manometry procedure, an average of 10 minutes
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)
Patients will be followed for the duration of outpatient anal rectal manometry procedure, an average of 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Jaime Belkind-Gerson, MD, MGH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimate)

February 18, 2013

Study Record Updates

Last Update Posted (Estimate)

September 14, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012P000231

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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