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

Interstitial Cystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195116
• Other study ID #: RSRB 31154
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2010
• Last updated: March 25, 2015
• Start date: May 2010
• Est. completion date: April 2012

Study information

• Verified date: March 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Pain, Postoperative

Intervention

Drug:
• Dexmedetomidine
1 mcg/kg/hour
• Normal Saline
1mcg/kg/hr

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No