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NCT Number: NCT03336801

The Effect of Propofol or Sevoflurane on Renal Function

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

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Key information

Conditions

Acute Kidney Injury Anesthesia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Akademiska sjukhuset, Centraloperation

Uppsala, 75185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Back Surgery

Procedure

All patients undergo basic back surgery.

Propofol

Drug

Anesthesia on propofol alone.

Sevoflurane

Drug

Anesthesia on sevoflurane alone.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Changes in electrolytes

    Time frame: 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

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • The Swedish Research Council

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 8, 2017
Registry last updated
Apr 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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