The Potential Renal Protective Effect of Intravenous Dexmedetomidine for Patients During Radical Cystectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Serum cystatin C level
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Dexmedetomidine
Patients received intravenous infusion of dexmedetomidine
Intervention: Dexmedetomidine (Drug)
Fentanyl
Patients received intravenous infusion of fentanyl
Intervention: Fentanyl (Drug)
Outcomes
Primary Outcomes
Serum cystatin C level
Time Frame: For 24 hours after surgery
Secondary Outcomes
- End-tidal carbon dioxide tension(For 8 hours after induction of general anesthesia)
- Total volume of crystalloid solutions used(For 8 hours after induction of general anesthesia)
- Post-operative eGFR(For 7 days after surgery)
- Total volume of colloid solutions used(For 8 hours after induction of general anesthesia)
- Serum creatinine(For 7 days after surgery)
- Heart rate(For 8 hours after induction of general anesthesia)
- Intraoperative occurrence of hypotension(For 8 hours after induction of general anesthesia)
- Mean arterial blood pressure(For 8 hours after induction of general anesthesia)
- Peripheral oxygen saturation (SpO2)(For 8 hours after induction of general anesthesia)
- Total volume of packed red blood cells transfused(For 8 hours after induction of general anesthesia)
- Intraoperative occurrence of bradycardia(For 8 hours after induction of general anesthesia)