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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
100
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.
Patients will receive Loading dose of fentanyl (1μg/kg), followed by intravenous infusion (1μg/kg/h) during intra-operative period till end of procedure.
Mansoura university
Al Mansurah, Dakahlia Governorate, Egypt
Serum cystatin C level
Time frame: For 24 hours after surgery
Serum creatinine
Daily morning over the first post-operative week
Time frame: For 7 days after surgery
Post-operative eGFR
daily within the first week post-operative
Time frame: For 7 days after surgery
Heart rate
recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: For 8 hours after induction of general anesthesia