Effect of Propofol on Internal Anal Sphincter Pressure During ARM

• ClinicalTrials.gov Identifier: NCT01793753
• Recruitment Status: Completed
• First Posted: February 18, 2013
• Last Update Posted: September 14, 2016
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Jaime Belkind-Gerson, MD, Massachusetts General Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Chronic Constipation	Drug: Propofol

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Study Start Date: October 2012
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: June 2013

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. 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)
2. 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)

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 6 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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

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

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Jaime Belkind-Gerson, MD, Medical Director, Neurogastroenterology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01793753
• Other Study ID Numbers: 2012P000231
• First Posted: February 18, 2013
• Last Update Posted: September 14, 2016
• Last Verified: September 2016

Additional relevant MeSH terms:

Constipation; Signs and Symptoms, Digestive; Signs and Symptoms; Propofol; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics