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

This study has been completed.
Information provided by (Responsible Party):
Suzanne Karan, University of Rochester Identifier:
First received: August 13, 2010
Last updated: March 25, 2015
Last verified: March 2015
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.

Condition Intervention Phase
Interstitial Cystitis
Drug: Dexmedetomidine
Drug: Normal Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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

Resource links provided by NLM:

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    It is a measurement instrument for subjective characteristics or attitudes towards pain that cannot be directly measured.

Enrollment: 41
Study Start Date: May 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Dexmedetomidine
1 mcg/kg/hour
Other Name: Precedex
Placebo Comparator: Normal Saline Drug: Normal Saline
Other Name: Sodium Chloride

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension for both diagnostic and therapeutic indications.
  • 2. 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.
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Please refer to this study by its identifier: NCT01195116

United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
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
  More Information

No publications provided

Responsible Party: Suzanne Karan, Principal investigator, University of Rochester Identifier: NCT01195116     History of Changes
Other Study ID Numbers: RSRB 31154
Study First Received: August 13, 2010
Results First Received: March 12, 2015
Last Updated: March 25, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Post-operative pain management
Pain Management
Painful bladder syndrome
frequency and urgency

Additional relevant MeSH terms:
Cystitis, Interstitial
Pain, Postoperative
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 25, 2015