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NCT Number: NCT03265470

Renal Protection of Intravenous Dexmedetomidine 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.

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Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university

Al Mansurah, Dakahlia Governorate, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Serum cystatin C level

    Time frame: For 24 hours after surgery

Secondary outcomes

  1. Serum creatinine

    Time frame: For 7 days after surgery

    Daily morning over the first post-operative week

  2. Post-operative eGFR

    Time frame: For 7 days after surgery

    daily within the first week post-operative

  3. Heart rate

    Time frame: For 8 hours after induction of general anesthesia

    recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin

  4. Mean arterial blood pressure

    Time frame: For 8 hours after induction of general anesthesia

    recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin

  5. Peripheral oxygen saturation (SpO2)

    Time frame: For 8 hours after induction of general anesthesia

    recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin

  6. End-tidal carbon dioxide tension

    Time frame: For 8 hours after induction of general anesthesia

    recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin

  7. Total volume of crystalloid solutions used

    Time frame: For 8 hours after induction of general anesthesia

    recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin

  8. Total volume of colloid solutions used

    Time frame: For 8 hours after induction of general anesthesia

    recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin

  9. Total volume of packed red blood cells transfused

    Time frame: For 8 hours after induction of general anesthesia

    recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin

  10. Intraoperative occurrence of hypotension

    Time frame: For 8 hours after induction of general anesthesia

    recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin

  11. Intraoperative occurrence of bradycardia

    Time frame: For 8 hours after induction of general anesthesia

    recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Aug 29, 2017
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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