Mansoura university
Al Mansurah, Dakahlia Governorate, 050, Egypt
NCT Number: NCT03265470
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.
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Notify Me20 year and older
All sexes
Interventional
Not applicable
Al Mansurah, Dakahlia Governorate, 050, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: For 24 hours after surgery
Time frame: For 7 days after surgery
Daily morning over the first post-operative week
Time frame: For 7 days after surgery
daily within the first week post-operative
Time frame: For 8 hours after induction of general anesthesia
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
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
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
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
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
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
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
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
recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin
Mansoura University
Other
The Potential Renal Protective Effect of Intravenous Dexmedetomidine for Patients During Radical Cystectomy
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