Effect of Propofol on Internal Anal Sphincter Pressure During ARM

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01793753
Study type	Observational
Source	Massachusetts General Hospital
Contact
Status	Completed
Phase	N/A
Start date	October 2012
Completion date	June 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05980988` - Effectiveness and Safety of Probiotic in Regulating Chronic Constipation	N/A
Recruiting	`NCT03819062` - Sacral Neuromodulation as Treatment for Chronic Constipation	N/A
Completed	`NCT00730171` - An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation	Phase 3
Completed	`NCT00765882` - Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation	Phase 3
Completed	`NCT00354575` - Effect of Chinese Herb on Chronic Constipation for Residents in Long-Term Care Units	Phase 2
Active, not recruiting	`NCT03119584` - Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation	Phase 4
Completed	`NCT00765999` - An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation	Phase 3
Completed	`NCT00746200` - Acupuncture for Chronic Constipation	Phase 3
Enrolling by invitation	`NCT00671684` - Endoscopic Mucosal Resection (EMR) for Diagnosis of Hirschsprung's Disease	Phase 1/Phase 2
Completed	`NCT00391820` - Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial)	Phase 2
Completed	`NCT00404040` - Movicol in Childhood Constipation (ProMotion Study)	Phase 2
Completed	`NCT02281630` - Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)	Phase 2
Completed	`NCT00256984` - Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)	Phase 4
Recruiting	`NCT05192317` - Administration of a Natural Molecular Complex in Functional Chronic Constipation	N/A
Active, not recruiting	`NCT05202028` - The Efficacy of Massage and Reflexology Applications in Children With Cerebral Palsy	N/A
Completed	`NCT05734859` - Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation	N/A
Completed	`NCT01007123` - Study of A3309 in Patients With Chronic Idiopathic Constipation	Phase 2
Completed	`NCT00402337` - Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation	Phase 2
Completed	`NCT02961556` - General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation	Phase 3
Recruiting	`NCT04869280` - Post-Marketing Study of Prucalopride Safety In Pregnancy