The Effect of Propofol or Sevoflurane on Renal Function

Study Overview
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Brief Summary
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This study investigates the role of the anesthetic agents propofol and sevoflurane on renal function in otherwise healthy patients undergoing basic back surgery.

Detailed Description
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Water-sodium homeostasis is central for anyone undergoing surgery, and can therefore affect surgical outcome, level of postoperative care and the length of hospital stay. Too much or too little fluid during surgery can affect the patients negatively. The kidneys play an imperative role in the regulation of water and sodium homeostasis, however there are lack of knowledge in how the anesthesia per se affects renal function. Previous studies have shown that volatile anesthetic agents such as sevoflurane can cause fluid retention. Why this happens is not completely known. We are now investigating the different affects of sevoflurane and propofol anesthesia on renal function in patients undergoing basic back surgery to elucidate if there is a difference in the risk of developing acute kidney injury.

Official Title
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The Effect of Propofol and Sevoflurane Anesthesia on Renal Function in Patients Undergoing Back Surgery

Conditions
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Acute Kidney Injury, Anesthesia

Intervention / Treatment
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* Procedure: Back Surgery
* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled back surgery Exclusion Criteria: American Association of Anesthesiology class 1-3 American Heart Association class >3 BMI >37 Insulin treated diabetes Pregnancy or breast feeding Sensistivity/allergy against anesthetic agents Inadequate understanding about the study Depressed kidney function and/or AKI Depressed liver function Genetic malignant hyperthermia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomized into one of two treatment groups which during surgery receives one of two different anesthetic agents. The two groups are then compared to each other.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sevoflurane<br>Intervention Back surgery and sevoflurane. | Procedure: Back Surgery<br>* All patients undergo basic back surgery.<br>Drug: Sevoflurane<br>* Anesthesia on sevoflurane alone.<br>|
| Active Comparator: Propofol<br>Intervention Back surgery and propofol. | Procedure: Back Surgery<br>* All patients undergo basic back surgery.<br>Drug: Propofol<br>* Anesthesia on propofol alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urine output | Urine output (ml/min) changes during anesthesia, in postoperative care and in the ward unit. Changes will be assessed with AKIN RIFLE and by comparison between the different groups. | 24 hours | 
| Change in serum creatinine levels | Changes in serum creatinine levels during anesthesia, in postoperative care and in the ward unit. Changes will be assessed with AKIN RIFLE and by comparison between the different groups. | 24 hours | 
| Change in creatinine clearance | Creatinine clearance changes during anesthesia, in postoperative care and in the ward unit. Changes will be assessed with AKIN RIFLE and by comparison between the different groups. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in electrolytes | Changes in serum and urinary electrolytes (sodium and potassium) will be measured during anesthesia, in postoperative care and in the ward unit. | 24 hours | 
| Changes in hormone levels | The hormones angiotensin II, anti diuretic hormone and aldosterone will be measured during anesthesia, in postoperative care and in the ward unit. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sevoflurane, propofol