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Effect of Propofol on Internal Anal Sphincter Pressure During ARM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01793753
Recruitment Status : Completed
First Posted : February 18, 2013
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Jaime Belkind-Gerson, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date February 5, 2013
First Posted Date February 18, 2013
Last Update Posted Date September 14, 2016
Study Start Date October 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 14, 2013)
  • 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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Propofol on Internal Anal Sphincter Pressure During ARM
Official Title Not Provided
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Chronically constipated children ages 2-6 years who will receive anesthesia for anorectal manometry including propofol per standard of care
Condition Chronic Constipation
Intervention Drug: Propofol
Study Groups/Cohorts Propofol
Chronically constipated children ages 2-6 years who will receive anesthesia for anorectal manometry including propofol per standard of care
Intervention: Drug: Propofol
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 14, 2013)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 6 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01793753
Other Study ID Numbers 2012P000231
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jaime Belkind-Gerson, MD, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jaime Belkind-Gerson, MD MGH
PRS Account Massachusetts General Hospital
Verification Date September 2016