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Effect of Propofol on Internal Anal Sphincter Pressure During ARM
NCT01793753 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Propofol
Study Locations (1)
Massachusetts
- Massachusetts General Hospital — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01793753
The ClinicalTrials.gov registry entry for NCT01793753 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 1,948 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Constipation appearing as the primary indexed condition, and to 1 intervention — of which Propofol is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01793753 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01793753 about?
NCT01793753 is a clinical study titled "Effect of Propofol on Internal Anal Sphincter Pressure During ARM". 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 ketami...
What is the current status of trial NCT01793753?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2012-10. Estimated completion is 2013-06.
What conditions does trial NCT01793753 study?
This clinical trial studies the following conditions: Chronic Constipation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01793753?
The interventions under investigation include: Propofol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01793753?
This trial is sponsored by Massachusetts General Hospital, which has 1,948 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01793753 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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