Radical Cystectomy
Conditions
Brief summary
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
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.
Interventions
DRUGDexmedetomidine
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.
DRUGFentanyl
Patients will receive Loading dose of fentanyl (1μg/kg), followed by intravenous infusion (1μg/kg/h) during intra-operative period till end of procedure.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum cystatin C level | For 24 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine | For 7 days after surgery | Daily morning over the first post-operative week |
| Post-operative eGFR | For 7 days after surgery | daily within the first week post-operative |
| Heart rate | For 8 hours after induction of general anesthesia | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin |
| Mean arterial blood pressure | For 8 hours after induction of general anesthesia | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin |
| Peripheral oxygen saturation (SpO2) | For 8 hours after induction of general anesthesia | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin |
| Total volume of crystalloid solutions used | For 8 hours after induction of general anesthesia | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin |
| Total volume of colloid solutions used | For 8 hours after induction of general anesthesia | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin |
| Total volume of packed red blood cells transfused | For 8 hours after induction of general anesthesia | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin |
| Intraoperative occurrence of hypotension | For 8 hours after induction of general anesthesia | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin |
| Intraoperative occurrence of bradycardia | For 8 hours after induction of general anesthesia | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin |
| End-tidal carbon dioxide tension | For 8 hours after induction of general anesthesia | recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin |
Countries
Egypt
Outcome results
None listed