Renal Protection of Intravenous Dexmedetomidine During Radical Cystectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dexmedetomidine Patients received intravenous infusion of dexmedetomidine |
Drug: Dexmedetomidine
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.
|
| Active Comparator: Fentanyl Patients received intravenous infusion of fentanyl |
Drug: Fentanyl
Patients will receive Loading dose of fentanyl (1μg/kg), followed by intravenous infusion (1μg/kg/h) during intra-operative period till end of procedure.
|
Outcome Measures
Primary Outcome Measures
- Serum cystatin C level [For 24 hours after surgery]
Secondary Outcome Measures
- 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
- 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
- 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
Eligibility Criteria
Criteria
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
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Allergy to any anesthetic drugs
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Uncontrolled hypertension.
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Uncontrolled diabetes.
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Heart block greater than first degree.
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History of alcohol abuse.
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History of drug abuse.
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Clinically significant neurologic disease.
-
Clinically significant cardiovascular disease.
-
Clinically significant respiratory disease.
-
Clinically significant hepatic disease.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mansoura university | Mansourah | Dakahlia | Egypt | 050 |
Sponsors and Collaborators
- Mansoura University
Investigators
- Study Chair: Golinar E Hammouda, MD, Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MD ∕ 15.08.78