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Clinical Trials/NCT01195116
NCT01195116
Completed
Phase 4

Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial Cystitis

University of Rochester1 site in 1 country41 target enrollmentMay 2010

Overview

Phase
Phase 4
Intervention
Dexmedetomidine
Conditions
Interstitial Cystitis
Sponsor
University of Rochester
Enrollment
41
Locations
1
Primary Endpoint
Change in Pain Score (1-10, 10 is Most Pain) From Baseline, to Average Post op Pain Score in PACU
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
April 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Suzanne Karan

Principal investigator

University of Rochester

Eligibility Criteria

Inclusion Criteria

  • Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension for both diagnostic and therapeutic indications.
  • Gender of Patients: Male \& female,Age of Patients: 18 and older

Exclusion Criteria

  • Conduction disturbance (second degree AV block or greater), or previous reaction to medications used in this study. Patients receiving spinal anesthesia will not be included.

Arms & Interventions

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.

Intervention: Dexmedetomidine

Normal Saline

Intervention: Normal Saline

Outcomes

Primary Outcomes

Change in Pain Score (1-10, 10 is Most Pain) From Baseline, to Average Post op Pain Score in PACU

Time Frame: Assessed every 15 minutes while in Post Anesthesia Care Unit until discharged home, which was approximately 10 times on the average

It is a measurement instrument for subjective characteristics or attitudes towards pain that cannot be directly measured.

Study Sites (1)

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