Metabolic Control in Anesthesia and Surgery (MACS)

Deteriorated Metabolic Control in the Perioperative Period in Surgical Patients: What is the Impact of Anesthetic Preparation and Patient Frailty?

The goal of this observational study is to investigate how a standard dose of the drug dexamethasone affects blood sugar levels during and after non-cardiac surgery in adult patients.

The main questions it aims to answer are:

• How does dexamethasone influence blood sugar levels in patients undergoing non-cardiac surgery?
• Does continuous glucose monitoring (CGM) provide a more accurate estimate of blood sugar fluctuations compared to traditional time-specific finger-prick measurements?

Participants are scheduled to receive dexamethasone as part of standard anesthesia care and will undergo their planned surgery. As part of the study, a continuous glucose monitoring (CGM) device will be placed on their upper arm approximately 12 hours before surgery and will remain in place for up to 10 days after the operation. During this period, their blood sugar levels will be measured using both the CGM device and traditional finger-prick tests. CGM readings are blinded for both participants and clinicians. No additional treatments or changes to their standard care will be made as a result of their participation in the study.

The study will include 100 adult patients from the Department of Anesthesiology at Sjællands University Hospital, Roskilde.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Surgical Procedure, Unspecified; Hyperglycemia Stress; Continuous Glucose Monitoring; Hyperglycemia Steroid-induced

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Anne M Brinck, MSc Medicine; Phone Number: +4552119003; Email: abrinc@regionsjaelland.dk

Study Locations

• Denmark
  • Roskilde, Denmark, 4000
    • Recruiting
    • Zealand University Hospital
    • Contact: Anne M Brinck, MSc Medicine; Phone Number: +4552119003; Email: abrinc@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult, surgical population where dexamethasone may be administered as part of anesthetic preparation of the patient for surgery.

Description

Inclusion Criteria:

• Adult patients (≥18 years) scheduled for elective non cardiac surgery
• Expected surgery duration >1 hour
• Administration of dexamethasone as part of standard anaesthetic regimen or planned by the responsible anaesthetist to enhance recovery or to limit risk of PONV.
• Ability to provide written informed consent

Exclusion Criteria:

• Not possible to obtain consent or permission
• Known allergy or adverse reaction to dexamethasone
• Type 1 diabetes (due to need for insulin titration)
• Active infection, sepsis, or immunosuppression
• Contraindications to continuous glucose monitoring (CGM)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterization of hyperglycemia I	Peak glucose level	Up to 10 days postoperatively
Characterization of hyperglycemia II	Duration of hyperglycemia	Up to 10 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between pre- and postoperative glucose trajectories	How does baseline dysglyceamia (elevated FPG or HbA1C) correlates to intra- and postoperative hyperglycemia	Up to 10 days postoperatively
Subgroup analyses	Comparing diabetic vs. non-diabetic patients and patients with obesity (BMI ≥30) vs. non-obese (BMI <30), frail vs non-frail, fasting vs non fasting surgeries	Up to 10 days postoperatively

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Investigators: Principal Investigator: Anne M Brinck, Msc Medicine, Zealand University Hospital, Roskilde, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SJ-1121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No