The Effect of Propofol or Sevoflurane on Renal Function

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336801
• Other study ID #: ANIMAL-523-2014-2569
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2017
• Est. completion date: January 10, 2020

Study information

• Verified date: April 2021
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 10, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Anesthesia

Intervention

Procedure:
• Back Surgery
All patients undergo basic back surgery.

Drug:
• Propofol
Anesthesia on propofol alone.
• Sevoflurane
Anesthesia on sevoflurane alone.

Locations

Country	Name	City	State
Sweden	Akademiska sjukhuset, Centraloperation	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours
Primary	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.	24 hours
Primary	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.	24 hours
Secondary	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.	24 hours
Secondary	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.	24 hours