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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Suzanne Karan, University of Rochester
ClinicalTrials.gov Identifier:
NCT01195116
First received: August 13, 2010
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
  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
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 49
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: Soudium 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Suzanne Karan, Principal investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01195116     History of Changes
Other Study ID Numbers: RSRB 31154
Study First Received: August 13, 2010
Last Updated: July 2, 2012
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
Dexmedetomidine
hydrodistension

Additional relevant MeSH terms:
Cystitis
Pain, Postoperative
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on May 23, 2013