The Effect of Propofol or Sevoflurane on Renal Function

Sponsor
Uppsala University (Other)
Overall Status
Completed
CT.gov ID
NCT03336801
Collaborator
The Swedish Research Council (Other)
37
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Investigator)
Primary Purpose:
Prevention
Official Title:
The Effect of Propofol and Sevoflurane Anesthesia on Renal Function in Patients Undergoing Back Surgery
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
Jan 10, 2020
Actual Study Completion Date :
Jan 10, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in urine output [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.

  2. Change in serum creatinine levels [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.

  3. Change in creatinine clearance [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 Outcome Measures

  1. Changes in electrolytes [24 hours]

    Changes in serum and urinary electrolytes (sodium and potassium) will be measured during anesthesia, in postoperative care and in the ward unit.

  2. Changes in hormone levels [24 hours]

    The hormones angiotensin II, anti diuretic hormone and aldosterone will be measured during anesthesia, in postoperative care and in the ward unit.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Akademiska sjukhuset, Centraloperation Uppsala Sweden 75185

Sponsors and Collaborators

  • Uppsala University
  • The Swedish Research Council

Investigators

  • Principal Investigator: Stephanie FranzĂ©n, PhD, Uppsala University, Department of Anesthesiology and Intensive Care
  • Study Director: Robert Frithiof, MD PhD, Uppsala University, Department of Anesthesiology and Intensive Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Robert Frithiof, MD PhD, Uppsala University
ClinicalTrials.gov Identifier:
NCT03336801
Other Study ID Numbers:
  • ANIMAL-523-2014-2569
First Posted:
Nov 8, 2017
Last Update Posted:
Apr 2, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Robert Frithiof, MD PhD, Uppsala University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 2, 2021