Clinical trial NCT03373266: Serun Fluoride and Kidney Transplant
Official title: Implication of Serum Fluoride Level Caused by Sevoflurane Versus Isoflurane Anesthesia Upon Renal Function After Kidney Transplantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Transplant; Complications
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* end stage renal disease

Exclusion Criteria:

-

Primary outcomes:
measure: Serum fluoride
timeFrame: baseline before anesthesia
measure: Serum fluoride
timeFrame: one hour postoperative
measure: serum fluoride
timeFrame: 6 hours postoperative
measure: Serum fluoride
timeFrame: 12 hours postoperative
measure: Serum fluoride
timeFrame: 24 hours postoperative
measure: Serum fluoride
timeFrame: 48 hours postoperative
Secondary outcomes:
measure: Serum creatinine
timeFrame: Baseline preoperative
measure: Serum creatinine
timeFrame: 24 hours postoperative
measure: Serum creatinine
timeFrame: 48 hours postoperative
measure: Serum creatinine
timeFrame: one week postoperative
measure: creatinine clearance
timeFrame: baseline before anesthesia
measure: creatinine clearance
timeFrame: 24 hours postoperative
measure: creatinine clearance
timeFrame: 48 hours postoperative
measure: creatinine clearance
timeFrame: one week postoperative
measure: Urine output
timeFrame: 24 hours postoperative
measure: Urine output
timeFrame: 48hours postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university faculty of medicine
Study officials:
affiliation: assiut university faculty of medicine
name: Abdelrady S Ibrahim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burchardi H, Kaczmarczyk G. The effect of anaesthesia on renal function. Eur J Anaesthesiol. 1994 May;11(3):163-8.