Metabolic Control in Anesthesia and Surgery

NCT07573930 | Recruiting

• 1 other identifier: SJ-1121
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Continuous Glucose Monitoring; Hyperglycemia Steroid-induced; Hyperglycemia Stress; Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Correlation between pre- and postoperative glucose trajectories

  Up to 10 days postoperatively

• Subgroup analyses

  Up to 10 days postoperatively

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital

Roskilde, 4000, Denmark

RECRUITING

Study Officials

• Anne M Brinck, Msc Medicine

  Zealand University Hospital, Roskilde, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne M Brinck, MSc Medicine

CONTACT

+4552119003; abrinc@regionsjaelland.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 7, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

DK (1)