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Completed

NCT Number: NCT01195116

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

1 mcg/kg/hour

Other names: Precedex

normal saline

Drug

1mcg/kg/hr

Other names: Sodium Chloride

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 3, 2010
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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