Chronic ConstipationNCT01793753
Effect of Propofol on Internal Anal Sphincter Pressure During ARM
An observational study of Chronic Constipation, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- Propofol
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Chronically constipated children ages 2-6 years who will receive anesthesia for anorectal manometry including propofol per standard of care
Who may be able to join
- Ages 2 - 6 years
- Chronic constipation
- Requires anorectal manometry
Who cannot join
- Ages 0-2 or > 6 years
- Abnormal anorectal anatomy
- Known history of Hirschsprung's Disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read more
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
- Being tested
- Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Chronically constipated children ages 2-6 years who will receive anesthesia for anorectal manometry including propofol per standard of care Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Patients will be followed for the duration of outpatient anal rectal manometry procedure, an average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic ConstipationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Belkind-Gerson, MD, Massachusetts General Hospital
- Investigators
- Jaime Belkind-Gerson, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793753
- Sponsor's protocol ID
- 2012P000231
- Status last verified
- Sep 2016
- First submitted
- 5 Feb 2013
- Last updated
- 14 Sep 2016
- Results posted
- No
Publications
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.
PubMed 24121151
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propofol on Internal Anal Sphincter Pressure During ARM
- ClinicalTrials.gov ID
- NCT01793753
- Acronym / sponsor ID
- 2012P000231
- Conditions
- Chronic Constipation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propofol | – | Drug: PropofolChronically constipated children ages 2-6 years who will receive anesthesia for anorectal manometry including propofol per standard of care |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Chronically constipated children ages 2-6 years who will receive anesthesia for anorectal manometry including propofol per standard of care
Key inclusion criteria (3 listed)
- Ages 2 - 6 years
- Chronic constipation
- Requires anorectal manometry
Key exclusion criteria (3 listed)
- Ages 0-2 or > 6 years
- Abnormal anorectal anatomy
- Known history of Hirschsprung's Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol | Drug | Propofol |
Primary outcome
Change in internal anal sphincter pressure from baseline
Time frame: Patients will be followed for the duration of outpatient anal rectal manometry procedure, an average of 10 minutes
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)
Time for internal anal sphincter pressure to return to baseline
Time frame: Patients will be followed for the duration of outpatient anal rectal manometry procedure, an average of 10 minutes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Derived from this study: PubMed 24121151Tran 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Belkind-Gerson, MD principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Constipation, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in internal anal sphincter pressure from baseline (time frame: Patients will be followed for the duration of outpatient anal rectal manometry procedure, an average of 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01793753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.