Combined Dexmedetomidine and Glycopyrrolate Therapy

Study Overview
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Brief Summary
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Catheter-related bladder discomfort after transurethral resection of bladder tumor is frequent because of indwelling urinary catheter for irrigation. The mechanism of the catheter-related bladder discomfort is similar to that of overactive bladder, in which muscarinic acetylcholine receptors are stimulated. The catheter-related bladder discomfort is a well known predisposing factor for emergence delirium after general anesthesia. In this study, we aimed to compare the incidence of catheter-related bladder discomfort between dexmedetomidine only therapy and combind dexmedetomidine and glycopyrrolate therapy.

Official Title
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Combined Dexmedetomidine and Glycopyrrolate Therapy for Prevention of Catheter Related Bladder Discomfort After Transurethral Bladder Surgery

Conditions
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Bladder Irritable

Intervention / Treatment
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* Drug: Glycopyrrolate + dexmedetomidine
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status I and II elective transurethral resection of bladder tumor under general anesthesia Exclusion Criteria: arrhythmia bladder outflow obstruction overacitve bladder end stage renal disease neurogenic bladder morbid obesity psychiatric disorder

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine only<br>dexmedetomidine is administered during the surgery | Drug: Dexmedetomidine<br>* Dexmedetomidine administration during the surgery.<br>|
| Experimental: Combined dexmedetomidine and glycopyrrolate<br>glycopyrrolate and dexmedetomidine are administered during the surgery | Drug: Glycopyrrolate + dexmedetomidine<br>* Intravenous glycopyrrolate before anesthetic induction. Dexmedetomidine administration during the surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of catheter-related bladder discomfort | No = not complaining of bladder discomfort on asking; Mild = report discomfot only on questioning; Moderate: report without questioning without behavior responses; Severe = report without questioniing accompanied by behavior responses. Mild, Moderate, Severe bladder discomfort is defined to have catheter-related bladder discomfort | 0 minute after entering the post-anesthetic care unit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence agitation | (1)calm (2)slightly agitated but consolable (3)moderately agitated and inconsolable (4)severely agitated and highly inconsolable | 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit | 
| Delirium | (1)acute and fluctuating changes in mental status (2)inattention (3)disorganized or incoherent thinking (4)altered level of consciousness. (1),(2) and (3), (1),(2), and (4), or (1)(2)(3)and (4) are defined to have deilrium. | 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit | 
| Postoperative pain | numerical rating scale (0=no pain to 10=worst pain imaginable) | 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit | 
| Sedation score | (1)anxious, agitated or restless (2)cooperative, oriented and trranquil (3)responds to commands, asleep (4)brisk response to light glabellar taps or oud noise (5)sluggish response to light glabellar taps or loud noise (6)noresponse | 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit | 
| Dry mouth | yes or no | 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit | 
| postoperative nausea and vomiting | yes or no | 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit |