Renal Protection of Intravenous Dexmedetomidine During Radical Cystectomy

NCT03265470 | Completed DMC

• 1 other identifier: MD ∕ 15.08.78
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Radical Cystectomy

Outcome Measures

Primary Outcomes (1)

• Serum cystatin C level

  For 24 hours after surgery

Secondary Outcomes (11)

• Serum creatinine

  For 7 days after surgery

• Post-operative eGFR

  For 7 days after surgery

• Heart rate

  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

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Patients received intravenous infusion of dexmedetomidine

Drug: Dexmedetomidine

Fentanyl

ACTIVE COMPARATOR

Patients received intravenous infusion of fentanyl

Drug: Fentanyl

Interventions

Dexmedetomidine DRUG

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.

Dexmedetomidine

Fentanyl DRUG

Patients will receive Loading dose of fentanyl (1μg/kg), followed by intravenous infusion (1μg/kg/h) during intra-operative period till end of procedure.

Fentanyl

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical status I or II.
• Patients scheduled for elective radical cystectomy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, Dakahlia Governorate, 050, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Officials

• Golinar E Hammouda, MD

  Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2017
• First Posted: August 29, 2017
• Study Start: December 1, 2015
• Primary Completion: March 30, 2020
• Study Completion: August 30, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

EG (1)