Renal Protection of Intravenous Dexmedetomidine During Radical Cystectomy

Radical Cystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265470
• Other study ID #: MD / 15.08.78
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: August 30, 2020

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Radical Cystectomy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Mansoura university	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum cystatin C level		For 24 hours after surgery
Secondary	Serum creatinine	Daily morning over the first post-operative week	For 7 days after surgery
Secondary	Post-operative eGFR	daily within the first week post-operative	For 7 days after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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