The Effect of Propofol or Sevoflurane on Renal Function

NCT ID: NCT03336801

Last Updated: 2021-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-01-10

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.

Conditions

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Acute Kidney Injury Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Sevoflurane

Intervention Back surgery and sevoflurane.

Group Type ACTIVE_COMPARATOR

Back Surgery

Intervention Type PROCEDURE

All patients undergo basic back surgery.

Sevoflurane

Intervention Type DRUG

Anesthesia on sevoflurane alone.

Propofol

Intervention Back surgery and propofol.

Group Type ACTIVE_COMPARATOR

Back Surgery

Intervention Type PROCEDURE

All patients undergo basic back surgery.

Propofol

Intervention Type DRUG

Anesthesia on propofol alone.

Interventions

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Back Surgery

All patients undergo basic back surgery.

Intervention Type PROCEDURE

Propofol

Anesthesia on propofol alone.

Intervention Type DRUG

Sevoflurane

Anesthesia on sevoflurane alone.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Robert Frithiof

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephanie Franzén, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University, Department of Anesthesiology and Intensive Care

Robert Frithiof, MD PhD

Role: STUDY_DIRECTOR

Uppsala University, Department of Anesthesiology and Intensive Care

Locations

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Akademiska sjukhuset, Centraloperation

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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ANIMAL-523-2014-2569

Identifier Type: -

Identifier Source: org_study_id

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