The Effect of Propofol or Sevoflurane on Renal Function

NCT03336801 | Completed Phase 4

• 1 other identifier: ANIMAL-523-2014-2569
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Anesthesia

Keywords

sevoflurane; propofol

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Changes in electrolytes

  24 hours

• Changes in hormone levels

  24 hours

Study Arms (2)

Sevoflurane

ACTIVE COMPARATOR

Intervention Back surgery and sevoflurane.

Procedure: Back Surgery; Drug: Sevoflurane

Propofol

ACTIVE COMPARATOR

Intervention Back surgery and propofol.

Procedure: Back Surgery; Drug: Propofol

Interventions

Back Surgery PROCEDURE

All patients undergo basic back surgery.

Propofol; Sevoflurane

Propofol DRUG

Anesthesia on propofol alone.

Propofol

Sevoflurane DRUG

Anesthesia on sevoflurane alone.

Sevoflurane

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled back surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead
• The Swedish Research Council: collaborator

Study Sites (1)

Akademiska sjukhuset, Centraloperation

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Stephanie Franzén, PhD

  Uppsala University, Department of Anesthesiology and Intensive Care

  PRINCIPAL INVESTIGATOR

• Robert Frithiof, MD PhD

  Uppsala University, Department of Anesthesiology and Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 8, 2017
• Study Start: September 1, 2017
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: April 2, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)