Propofol and Sevoflurane Anesthesia in Colorectal Cancer Surgery: Incidence of Acute Kidney Injury

Active, not recruiting

• Conditions: Acute Kidney Injury; Cancer Colorectal
• Interventions: Drug: Anesthesia Agent

• Registration Number: NCT05585866
• Lead Sponsor: Uppsala University

Brief Summary

The goal of this observational study is to compare anesthetic modalities (intravenous propofol anesthesia with sevoflurane gas anesthesia) in patients who underwent colorectal cancer resection surgery regarding the outcome of acute kidney injury.

The main questions it aims to answer are:

* is there a difference in acute kidney injury incidence in the two anesthetic modalities?

* is there a difference in plasma creatinine between the two anesthetic modalities?

* are there any patient characteristics or intraoperative factors that effect the incidence of acute kidney injury in either anesthetic modality?

The study will analyze data from the CAN clinical trial database. (Cancer and Anesthesia: Survival After Radical Surgery - a Comparison Between Propofol or Sevoflurane Anesthesia, NCT01975064)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-22
• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-19
• Primary Completion: 2022-10-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• colorectal surgery and participant in the CAN trial

Exclusion Criteria

• missing blood samples

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sevoflurane	Anesthesia Agent	The group of patients which received sevoflurane as randomized anesthetic modality.
Propofol	Anesthesia Agent	The group of patients which received propofol as randomized anesthetic modality.

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury	Within 10 days of surgery	Compare the incidence of AKI (n, %) in the two anesthetic modalities. Number of participants (n, %) with AKI and number of participants (n, %) with AKI stage 1-3 within the different anesthetic modalities at 0-3 days and 4-10 days postoperatively. KDIGO (Kidney Disease: Improving Global Outcome) criteria for plasma creatinine are used as criteria for AKI. The highest value of plasma creatinine within the time frame will be used to define AKI stage.
Changes in plasma creatinine	Within 30 days of surgery	Changes in plasma creatinine over time in both groups of anesthesia. Plasma creatinine from preoperative, postoperative after 0-3 days, postoperative 4-10 days and after 30 days. Maximum plasma creatinine for each participant at these time point will be used in the regression analysis.

Secondary Outcome Measures

Name	Time	Method
AKI incidence in the cardiovascular disease population	Within 10 days of surgery	Compare the incidence of AKI (n, %) during the two anesthetic modalities in the population with present cardiovascular disease. Classified according to KDIGO AKI stage 1-3 changes in plasma creatinine. The highest value of plasma creatinine within the time frame will be used to define AKI stage.
Association of sex on AKI incidence	Within 10 days of surgery	Compare the incidence of AKI (n, %) in men vs women. This analysis will be done in both groups separately and in the entire population independent of anesthetic modality.
Association of age on AKI incidence	Within 10 days of surgery	Compare the incidence of AKI (n, %) in participants older vs younger than 65. This analysis will be done in both groups separately and in the entire population independent of anesthetic modality.

Trial Locations

Locations (1)

Uppsala University; 🇸🇪 Uppsala, Sweden