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Clinical Trials/NCT03336801
NCT03336801
Completed
Phase 4

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

Uppsala University1 site in 1 country37 target enrollmentSeptember 1, 2017

Overview

Phase
Phase 4
Intervention
Back Surgery
Conditions
Acute Kidney Injury
Sponsor
Uppsala University
Enrollment
37
Locations
1
Primary Endpoint
Change in urine output
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
January 10, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Principal Investigator
Principal Investigator

Robert Frithiof

MD PhD

Uppsala University

Eligibility Criteria

Inclusion Criteria

  • Scheduled back surgery

Exclusion Criteria

  • American Association of Anesthesiology class 1-3
  • American Heart Association class \>3
  • 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

Arms & Interventions

Sevoflurane

Intervention Back surgery and sevoflurane.

Intervention: Back Surgery

Sevoflurane

Intervention Back surgery and sevoflurane.

Intervention: Sevoflurane

Propofol

Intervention Back surgery and propofol.

Intervention: Back Surgery

Propofol

Intervention Back surgery and propofol.

Intervention: Propofol

Outcomes

Primary Outcomes

Change in urine output

Time Frame: 24 hours

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.

Change in serum creatinine levels

Time Frame: 24 hours

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.

Change in creatinine clearance

Time Frame: 24 hours

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.

Secondary Outcomes

  • Changes in electrolytes(24 hours)
  • Changes in hormone levels(24 hours)

Study Sites (1)

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