Renal Protection of Intravenous Dexmedetomidine During Radical Cystectomy

The Potential Renal Protective Effect of Intravenous Dexmedetomidine for Patients During Radical Cystectomy

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.

Study Overview

• Status: Completed
• Conditions: Radical Cystectomy
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Fentanyl

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansourah, Dakahlia, Egypt, 050
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum cystatin C level	For 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum creatinine	Daily morning over the first post-operative week	For 7 days after surgery
Post-operative eGFR	daily within the first week post-operative	For 7 days after surgery
Heart rate	recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin	For 8 hours after induction of general anesthesia
Mean arterial blood pressure	recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin	For 8 hours after induction of general anesthesia
Peripheral oxygen saturation (SpO2)	recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin	For 8 hours after induction of general anesthesia
End-tidal carbon dioxide tension	recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin	For 8 hours after induction of general anesthesia
Total volume of crystalloid solutions used	recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin	For 8 hours after induction of general anesthesia
Total volume of colloid solutions used	recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin	For 8 hours after induction of general anesthesia
Total volume of packed red blood cells transfused	recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin	For 8 hours after induction of general anesthesia
Intraoperative occurrence of hypotension	recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin	For 8 hours after induction of general anesthesia
Intraoperative occurrence of bradycardia	recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin	For 8 hours after induction of general anesthesia

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: August 26, 2017
• First Submitted That Met QC Criteria: August 26, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 5, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Dexmedetomidine
• Other Study ID Numbers: MD ∕ 15.08.78

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED