The Effect of Propofol or Sevoflurane on Renal Function

Phase 4

Completed

• Conditions: Anesthesia; Acute Kidney Injury
• Interventions: Procedure: Back Surgery; Drug: Sevoflurane; Drug: Propofol

• Registration Number: NCT03336801
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-08
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-01
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Back Surgery	Intervention Back surgery and propofol.
Sevoflurane	Back Surgery	Intervention Back surgery and sevoflurane.
Sevoflurane	Sevoflurane	Intervention Back surgery and sevoflurane.
Propofol	Propofol	Intervention Back surgery and propofol.

Primary Outcome Measures

Name	Time	Method
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.
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.
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Akademiska sjukhuset, Centraloperation; 🇸🇪 Uppsala, Sweden