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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | Patients received intravenous infusion of dexmedetomidine |
|
| Fentanyl | Active Comparator | Patients received intravenous infusion of fentanyl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum cystatin C level | For 24 hours after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Golinar E Hammouda, MD | Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura university | Al Mansurah | Dakahlia Governorate | 050 | Egypt |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fentanyl | Drug | Patients will receive Loading dose of fentanyl (1μg/kg), followed by intravenous infusion (1μg/kg/h) during intra-operative period till end of procedure. |
|
| 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 |
| D010880 |
| Piperidines |