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

NCT01195116 | Completed Phase 4 Results DMC

• 1 other identifier: RSRB 31154
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Cystitis

Keywords

Post-operative pain management; Pain Management; Painful bladder syndrome; frequency and urgency; Dexmedetomidine; hydrodistension

Outcome Measures

Primary Outcomes (1)

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

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

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

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

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

Normal Saline

PLACEBO COMPARATOR

Drug: Normal Saline

Interventions

Dexmedetomidine DRUG

1 mcg/kg/hour

Also known as: Precedex

Dexmedetomidine

Normal Saline DRUG

1mcg/kg/hr

Also known as: Sodium Chloride

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial; Agnosia

Interventions

Dexmedetomidine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Suzanne Karan
• Organization: University of Rochester

suzanne_karan@urmc.rochester.edu

5852751384

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: September 3, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 15, 2015
• Results First Posted: March 24, 2015

Record last verified: 2015-03

Locations

US (1)