Clinical trial NCT03265470: Renal Protection of Intravenous Dexmedetomidine During Radical Cystectomy
Official title: The Potential Renal Protective Effect of Intravenous Dexmedetomidine for Patients During Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radical Cystectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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
* 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.

Primary outcomes:
measure: Serum cystatin C level
timeFrame: For 24 hours after surgery
Secondary outcomes:
measure: Serum creatinine
timeFrame: For 7 days after surgery
measure: Post-operative eGFR
timeFrame: For 7 days after surgery
measure: Heart rate
timeFrame: For 8 hours after induction of general anesthesia
measure: Mean arterial blood pressure
timeFrame: For 8 hours after induction of general anesthesia
measure: Peripheral oxygen saturation (SpO2)
timeFrame: For 8 hours after induction of general anesthesia
measure: End-tidal carbon dioxide tension
timeFrame: For 8 hours after induction of general anesthesia
measure: Total volume of crystalloid solutions used
timeFrame: For 8 hours after induction of general anesthesia
measure: Total volume of colloid solutions used
timeFrame: For 8 hours after induction of general anesthesia
measure: Total volume of packed red blood cells transfused
timeFrame: For 8 hours after induction of general anesthesia
measure: Intraoperative occurrence of hypotension
timeFrame: For 8 hours after induction of general anesthesia
measure: Intraoperative occurrence of bradycardia
timeFrame: For 8 hours after induction of general anesthesia
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university
state: Dakahlia
Study officials:
affiliation: Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
name: Golinar E Hammouda, MD
role: STUDY_CHAIR
References: