Effect of Propofol on Internal Anal Sphincter Pressure During ARM

NCT01793753 | Completed

• 1 other identifier: 2012P000231
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Constipation

Outcome Measures

Primary Outcomes (2)

• Change in internal anal sphincter pressure from baseline

  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

  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

Study Arms (1)

Propofol

Chronically constipated children ages 2-6 years who will receive anesthesia for anorectal manometry including propofol per standard of care

Drug: Propofol

Interventions

Propofol DRUG

Propofol

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 24121151 DERIVED

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jaime Belkind-Gerson, MD

  MGH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Neurogastroenterology

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 18, 2013
• Study Start: October 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 14, 2016

Record last verified: 2016-09

Locations

US (1)