Effect of Propofol on Internal Anal Sphincter Pressure During ARM

NCT ID: NCT01793753

Last Updated: 2016-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-06-30

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Propofol

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

Propofol

Intervention Type: DRUG

Interventions

Propofol

Intervention Type: DRUG

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jaime Belkind-Gerson, MD

Medical Director, Neurogastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaime Belkind-Gerson, MD

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24121151 (View on PubMed)

Other Identifiers

2012P000231

Identifier Type: -

Identifier Source: org_study_id