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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01195116
First Posted: September 3, 2010
Last Update Posted: April 15, 2015
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.
Information provided by (Responsible Party):
Suzanne Karan, University of Rochester
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Suzanne Karan, 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 ]
    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
1mcg/kg/hr
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01195116


Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
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

Responsible Party: Suzanne Karan, Principal investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01195116     History of Changes
Other Study ID Numbers: RSRB 31154
First Submitted: August 13, 2010
First Posted: September 3, 2010
Results First Submitted: March 12, 2015
Results First Posted: March 24, 2015
Last Update Posted: April 15, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Pain, Postoperative
Cystitis
Cystitis, Interstitial
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action