Radical CystectomyNCT03265470
Renal Protection of Intravenous Dexmedetomidine During Radical Cystectomy
A study testing Dexmedetomidine and Fentanyl in people with Radical Cystectomy, run by Mansoura University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Radical Cystectomy
- What is being tested?
- Dexmedetomidine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2015to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status I or II.
- Patients scheduled for elective radical cystectomy.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Radical Cystectomy
- Being tested
- Dexmedetomidine, Fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
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.
FentanylDrug
Patients will receive Loading dose of fentanyl (1μg/kg), followed by intravenous infusion (1μg/kg/h) during intra-operative period till end of procedure.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Patients received intravenous infusion of dexmedetomidine Receives: Drug: Dexmedetomidine |
| Fentanyl | Active comparator | Patients received intravenous infusion of fentanyl Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum cystatin C level
Measured: For 24 hours after surgery
Secondary outcomes (11)
Serum creatinine
Daily morning over the first post-operative week
Measured: For 7 days after surgery
Post-operative eGFR
daily within the first week post-operative
Measured: For 7 days after surgery
Heart rate
recorded immediately after intubation, every 30 min during surgery and immediately after closure of the skin
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: For 8 hours after induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Dec 2015
- Primary completion30 Mar 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radical CystectomyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Golinar E Hammouda, MD, Study chair, Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265470
- Sponsor's protocol ID
- MD ∕ 15.08.78
- Status last verified
- Sep 2020
- First submitted
- 26 Aug 2017
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Renal Protective Effect of Intravenous Dexmedetomidine for Patients During Radical Cystectomy
- ClinicalTrials.gov ID
- NCT03265470
- Acronym / sponsor ID
- MD ∕ 15.08.78
- Conditions
- Radical Cystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidinePatients received intravenous infusion of dexmedetomidine |
| Fentanyl | Active comparator | Drug: FentanylPatients received intravenous infusion of fentanyl |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status I or II.
- Patients scheduled for elective radical cystectomy.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidinePatients 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. | Drug | Dexmedetomidine |
| FentanylPatients will receive Loading dose of fentanyl (1μg/kg), followed by intravenous infusion (1μg/kg/h) during intra-operative period till end of procedure. | Drug | Fentanyl |
Primary outcome
Serum cystatin C level
Time frame: For 24 hours after surgery
11 secondary outcomes
Serum creatinine
Time frame: For 7 days after surgery
Post-operative eGFR
Time frame: For 7 days after surgery
Heart rate
Time frame: For 8 hours after induction of general anesthesia
Mean arterial blood pressure
Time frame: For 8 hours after induction of general anesthesia
Peripheral oxygen saturation (SpO2)
Time frame: For 8 hours after induction of general anesthesia
End-tidal carbon dioxide tension
Time frame: For 8 hours after induction of general anesthesia
Total volume of crystalloid solutions used
Time frame: For 8 hours after induction of general anesthesia
Total volume of colloid solutions used
Time frame: For 8 hours after induction of general anesthesia
Total volume of packed red blood cells transfused
Time frame: For 8 hours after induction of general anesthesia
Intraoperative occurrence of hypotension
Time frame: For 8 hours after induction of general anesthesia
Intraoperative occurrence of bradycardia
Time frame: For 8 hours after induction of general anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Golinar E Hammouda, MD study chair
Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Fentanyl in people with Radical Cystectomy, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum cystatin C level (time frame: For 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.