Serun Fluoride and Kidney Transplant

Study Overview
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Brief Summary
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Our primary goal is to investigate any hidden burden upon the grafted kidney from the increase of serum fluoride resulted from sevoflurane, versus isoflurane.

Detailed Description
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Eighty patients with end stage renal failure undergoing living donor kidney transplant under general anesthesia were included in this study, by using an open (non-blinded) study design, patients were randomly assigned to two groups, 15 patients in each. Randomization was done through computer generated random tables. Isoflurane group; anesthesia was maintained with isoflurane 1-2%. Sevoflurane group; anesthesia was maintained with Sevoflurane 1-2%. A peripheral intravenous access was secured in the hand opposite to the functioning fistula and induction of anesthesia was done with propofol 2mg/kg, neuromuscular blockade was maintained with atracurium 0.6mg/kg and all patients were intubated and ventilated to maintain end-tidal carbon dioxide (ETCO2) concentration between 30-40 mmHg. Anaesthesia was maintained with 1-2% isoflurane (isoflurane group) or 1-2% sevoflurane (sevoflurane group) with fresh gas flow of 2 L/min. In both groups inhalational anesthetic was delivered in an air-oxygen mixture of 1:1 ratio. Analgesia was maintained with fentanyl 1µg/kg/hr. Mannitol and sodium bicarbonate was given immediately before reperfusion (de-clamping of renal artery). Intraoperative monitoring included heart rate, noninvasive blood pressure, oxygen saturation, ETCO2, ECG and central venous line was placed in the right or left internal jugular vein depending upon the presence of dialysis catheter. Hemodynamic target include: mean arterial pressure of > 80mmHg, CVP between 10-15 mm Hg to optimize cardiac output and renal blood flow.

Official Title
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Implication of Serum Fluoride Level Caused by Sevoflurane Versus Isoflurane Anesthesia Upon Renal Function After Kidney Transplantation.

Conditions
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Kidney Transplant; Complications

Intervention / Treatment
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* Drug: Sevoflurane
* Drug: Isoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: end stage renal disease Exclusion Criteria: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sevoflurane<br>anesthesia was maintained with Sevoflurane 1-2%. | Drug: Sevoflurane<br>* anesthesia was maintained with Sevoflurane 1-2%.<br>* Other names: Inhalational anesthetic;|
| Active Comparator: isoflurane<br>anesthesia was maintained with isoflurane 1-2%. | Drug: Isoflurane<br>* anesthesia was maintained with isoflurane 1-2%.<br>* Other names: Inhalational anesthetic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum fluoride | Serum inorganic fluoride | baseline before anesthesia | 
| Serum fluoride | Serum inorganic fluoride | one hour postoperative | 
| serum fluoride | Serum inorganic fluoride | 6 hours postoperative | 
| Serum fluoride | Serum inorganic fluoride | 12 hours postoperative | 
| Serum fluoride | Serum inorganic fluoride | 24 hours postoperative | 
| Serum fluoride | Serum inorganic fluoride | 48 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine | kidney function | Baseline preoperative | 
| Serum creatinine | kidney function | 24 hours postoperative | 
| Serum creatinine | kidney function | 48 hours postoperative | 
| Serum creatinine | kidney function | one week postoperative | 
| creatinine clearance | kidney function | baseline before anesthesia | 
| creatinine clearance | kidney function | 24 hours postoperative | 
| creatinine clearance | kidney function | 48 hours postoperative | 
| creatinine clearance | kidney function | one week postoperative | 
| Urine output | kidney function | 24 hours postoperative | 
| Urine output | kidney function | 48hours postoperative |