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The Effect of Propofol or Sevoflurane on Renal Function

Primary Purpose

Acute Kidney Injury, Anesthesia

Status

Completed

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

Back Surgery

Propofol

Sevoflurane

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring sevoflurane, propofol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Akademiska sjukhuset, Centraloperation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Sevoflurane

Propofol

Arm Description

Intervention Back surgery and sevoflurane.

Intervention Back surgery and propofol.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03336801

First Posted

November 6, 2017

Last Updated

April 1, 2021

Sponsor

Uppsala University

Collaborators

The Swedish Research Council

1. Study Identification

Unique Protocol Identification Number

NCT03336801

Brief Title

The Effect of Propofol or Sevoflurane on Renal Function

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

January 10, 2020 (Actual)

Study Completion Date

January 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Uppsala University

Collaborators

The Swedish Research Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury, Anesthesia

Keywords

sevoflurane, propofol

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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

Investigator

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sevoflurane

Arm Type

Active Comparator

Arm Description

Intervention Back surgery and sevoflurane.

Arm Title

Propofol

Arm Type

Active Comparator

Arm Description

Intervention Back surgery and propofol.

Intervention Type

Procedure

Intervention Name(s)

Back Surgery

Intervention Description

All patients undergo basic back surgery.

Intervention Type

Drug

Intervention Name(s)

Propofol

Intervention Description

Anesthesia on propofol alone.

Intervention Type

Drug

Intervention Name(s)

Sevoflurane

Intervention Description

Anesthesia on sevoflurane alone.

Primary Outcome Measure Information:

Title

Change in urine output

Description

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.

Time Frame

24 hours

Title

Change in serum creatinine levels

Description

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.

Time Frame

24 hours

Title

Change in creatinine clearance

Description

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.

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Changes in electrolytes

Description

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

Time Frame

24 hours

Title

Changes in hormone levels

Description

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

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephanie Franzén, PhD

Organizational Affiliation

Uppsala University, Department of Anesthesiology and Intensive Care

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert Frithiof, MD PhD

Organizational Affiliation

Uppsala University, Department of Anesthesiology and Intensive Care

Official's Role

Study Director

Facility Information:

Facility Name

Akademiska sjukhuset, Centraloperation

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Effect of Propofol or Sevoflurane on Renal Function

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