Renal Protection of Intravenous Dexmedetomidine During Radical Cystectomy

Study Overview
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Brief Summary
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Acute kidney injury and chronic kidney disease usually associated with radical cystectomy operation which is the treatment of choice for invasive urinary bladders tumor. Peri-operative acute kidney injury (AKI) is common but poorly recognized and managed which is associated with increase surgical morbidity and mortality and hospital cost .Prospective human studies establishing a renal protective effect of dexmedetomidine are still questionable.

Detailed Description
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The aim of this study is to test the hypothesis that intra-operative intravenous dexmedetomidine infusion could improve early renal function after open radical cystectomy. This randomized comparative study will be carried out on 100 patients of either sex, ASA I and II with baseline serum creatinine below 1.4 mg/dl who will be submitted for radical cystectomy. The patients will be randomly allocated into two groups according to the drug infused intra-operatively; dexmedetomidine group and fentanyl group. Dexmedetomidine group: will receive loading dose (0.8μg/kg) over 20 minutes, followed by intravenous infusion (0.4μg/kg/h) and fentanyl group: will receive loading dose (1μg/kg), followed by intravenous infusion (1μg/kg/h) during intra-operative period till end of procedure. Assessment of renal function through evaluation of pre-operative estimated glomerular filtration rate (eGFR) using Modification of Diet in Renal Disease (MDRD) formula based on baseline serum creatinine, serum cystatin C level at 24 hours post-operative, daily post-operative serum creatinine for one week post-operative and post-operative eGFR using MDRD formula.

Official Title
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The Potential Renal Protective Effect of Intravenous Dexmedetomidine for Patients During Radical Cystectomy

Conditions
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Radical Cystectomy

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status I or II. Patients scheduled for elective radical cystectomy. Exclusion Criteria: Serum creatinine level equal or greater than 1.4 mg/dl. Allergy to alpha-2 adrenergic agonist Allergy to any anesthetic drugs Uncontrolled hypertension. Uncontrolled diabetes. Heart block greater than first degree. History of alcohol abuse. History of drug abuse. Clinically significant neurologic disease. Clinically significant cardiovascular disease. Clinically significant respiratory disease. Clinically significant hepatic disease.

Ages Eligible for Study
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Minimum Age: 20 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Patients received intravenous infusion of dexmedetomidine | Drug: Dexmedetomidine<br>* Patients will receive Loading dose of dexmedetomidine (0.8μg/kg) over 20 minutes, followed by intravenous infusion (0.4μg/kg/h) during intra-operative period till end of procedure.<br>|
| Active Comparator: Fentanyl<br>Patients received intravenous infusion of fentanyl | Drug: Fentanyl<br>* Patients will receive Loading dose of fentanyl (1μg/kg), followed by intravenous infusion (1μg/kg/h) during intra-operative period till end of procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum cystatin C level |  | For 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine | Daily morning over the first post-operative week | For 7 days after surgery | 
| Post-operative eGFR | daily within the first week post-operative | For 7 days after surgery | 
| Heart rate | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin | For 8 hours after induction of general anesthesia | 
| Mean arterial blood pressure | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin | For 8 hours after induction of general anesthesia | 
| Peripheral oxygen saturation (SpO2) | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin | For 8 hours after induction of general anesthesia | 
| End-tidal carbon dioxide tension | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin | For 8 hours after induction of general anesthesia | 
| Total volume of crystalloid solutions used | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin | For 8 hours after induction of general anesthesia | 
| Total volume of colloid solutions used | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin | For 8 hours after induction of general anesthesia | 
| Total volume of packed red blood cells transfused | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin | For 8 hours after induction of general anesthesia | 
| Intraoperative occurrence of hypotension | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin | For 8 hours after induction of general anesthesia | 
| Intraoperative occurrence of bradycardia | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin | For 8 hours after induction of general anesthesia |