Renal Protection of Intravenous Dexmedetomidine During Radical Cystectomy

Mansoura University

Status: Completed

Conditions: Radical Cystectomy

Treatments: Drug: Dexmedetomidine; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03265470

MD ∕ 15.08.78

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Dexmedetomidine

Experimental group

Description:

Patients received intravenous infusion of dexmedetomidine

Treatment:

Drug: Dexmedetomidine

Fentanyl

Active Comparator group

Description:

Patients received intravenous infusion of fentanyl

Treatment:

Drug: Fentanyl