The Effect of Propofol or Sevoflurane on Renal Function

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

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

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Anesthesia
• Intervention / Treatment: Procedure: Back Surgery; Drug: Sevoflurane; Drug: Propofol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 75185
    • Akademiska sjukhuset, Centraloperation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: The Swedish Research Council
• Investigators: Principal Investigator: Stephanie Franzén, PhD, Uppsala University, Department of Anesthesiology and Intensive Care; Study Director: Robert Frithiof, MD PhD, Uppsala University, Department of Anesthesiology and Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): January 10, 2020

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 2, 2021
• Last Update Submitted That Met QC Criteria: April 1, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: sevoflurane; propofol
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: ANIMAL-523-2014-2569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No