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NCT01793753 · ClinicalTrials.gov registry record
Effect of Propofol on Internal Anal Sphincter Pressure During ARM
A clinical trial of Chronic Constipation, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT01793753: Completed study of Chronic Constipation, sponsored by Massachusetts General Hospital.
NCT01793753 is a study of Chronic Constipation that has completed, run by Massachusetts General Hospital. The registered enrollment target is 20 participants, below the 788-participant average among 4 other Chronic Constipation trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01793753, a study of Chronic Constipation, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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)
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 |
What the finished NCT01793753 record still lists
NCT01793753 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 788-participant average among 4 other Chronic Constipation trials with a reported enrollment target (97% lower).
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.
NCT01793753 reports a single indexed study location in Massachusetts.
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.
What interventions are being tested in trial NCT01793753?
The interventions under investigation include: Propofol (DRUG).
Who is sponsoring clinical trial NCT01793753?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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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