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Trial record 22 of 158 for:    interstitial cystitis

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

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ClinicalTrials.gov Identifier: NCT01195116
Recruitment Status : Completed
First Posted : September 3, 2010
Results First Posted : March 24, 2015
Last Update Posted : April 15, 2015
Sponsor:
Information provided by (Responsible Party):
Suzanne Karan, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Interstitial Cystitis
Interventions Drug: Dexmedetomidine
Drug: Normal Saline
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dexmedetomidine Normal Saline
Hide Arm/Group Description

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.

Dexmedetomidine: 1 mcg/kg/hour

Normal Saline: 1mcg/kg/hr
Period Title: Overall Study
Started 21 20
Completed 21 20
Not Completed 0 0
Arm/Group Title Dexmedetomidine Normal Saline Total
Hide Arm/Group Description

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.

Dexmedetomidine: 1 mcg/kg/hour

Normal Saline: 1mcg/kg/hr Total of all reporting groups
Overall Number of Baseline Participants 21 20 41
Hide Baseline Analysis Population Description
subjects were recruited if they were scheduled for bladder lavage under general anesthesia for the treatment of interstitial cystitis
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 20 participants 41 participants
48.32  (10.98) 45.25  (15.25) 47  (13.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 41 participants
Female
19
  90.5%
20
 100.0%
39
  95.1%
Male
2
   9.5%
0
   0.0%
2
   4.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 20 participants 41 participants
21 20 41
1.Primary Outcome
Title Change in Pain Score (1-10, 10 is Most Pain) From Baseline, to Average Post op Pain Score in PACU
Hide Description It is a measurement instrument for subjective characteristics or attitudes towards pain that cannot be directly measured.
Time Frame Assessed every 15 minutes while in Post Anesthesia Care Unit until discharged home, which was approximately 10 times on the average
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Normal Saline
Hide Arm/Group Description:

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.

Dexmedetomidine: 1 mcg/kg/hour

Normal Saline: 1mcg/kg/hr
Overall Number of Participants Analyzed 21 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.46  (3.33) -.025  (4.88)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexmedetomidine Normal Saline
Hide Arm/Group Description

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.

Dexmedetomidine: 1 mcg/kg/hour

Normal Saline: 1mcg/kg/hr
All-Cause Mortality
Dexmedetomidine Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dexmedetomidine Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dexmedetomidine Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Suzanne Karan
Organization: University of Rochester
Phone: 5852751384
Responsible Party: Suzanne Karan, 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