Usefulnessof Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial Cystitis
The purpose of this study is to assess the effects of dexmedetomidine while patients undergo treatment for Interstitial Cystitis (IC). The investigators goal is to demonstrate in patients with IC undergoing bladder hydrodistension that the use of dexmedetomidine as a supplemental anesthetic agent will result in better postoperative pain management.
Drug: Normal Saline
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial Cystitis|
- Maximum pain reported on Visual Analogue Scale (VAS) [ Time Frame: Assessed every 15 minutes while in Post Anesthesia Care Unit until discharged home ] [ Designated as safety issue: No ]It is a measurement instrument for subjective characteristics or attitudes towards pain that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
- PACU opiate use [ Time Frame: Assessed every 15 minutes while in Post Anesthesia Care Unit until discharged home ] [ Designated as safety issue: No ]Opiate use following procedure will be quantified for all subjects
- Total time until discharge [ Time Frame: Assessed once at time of discharge home on study day 1 ] [ Designated as safety issue: No ]Total time subject is at hospital for completion and recovery of procedure will be monitored
|Study Start Date:||May 2010|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Dexmedetomidine
Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.
Other Name: Precedex
|Placebo Comparator: Normal Saline||
Drug: Normal Saline
Other Name: Soudium Chloride
Inclusion Criteria: Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension for both diagnostic and therapeutic indications.
Data collected will include:
I. Postoperative Outcomes i. Pain Reported (Visual Analogue Scale) ii. Post-operative opiate use iii. Time in PACU iv. Time until discharge v. Adverse Events (i.e. nausea/vomiting, nursing intervention) II. Intermediate-term Outcomes (4-6 weeks) i. Interstitial Cystitis Symptom & Problem Index ii. Revised McGill Pain Score
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195116
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Suzanne Karan, MD||University of Rochester Department of Affiliation|
|Principal Investigator:||Robert Mayer, MD||University of Rochester Department of Urology|
|Principal Investigator:||Denham Ward, MD, PhD||University of Rochester Department of Anesthesiology|