Metabolic Control in Anesthesia and Surgery | NCT07573930

Studies
Metabolic Control in Anesthesia and Surgery

NCT07573930

Sponsor

Zealand University Hospital

Status

Recruiting

Last Update Posted

May 7, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 23, 2026Actual

Primary Completion Date

Jul 1, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Apr 27, 2026

First Submission Date that Met QC Criteria

May 4, 2026

First Posted Date

May 7, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2026

Last Update Posted Date

May 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anne M Brinck, MSc Medicine	Contact	+4552119003		abrinc@regionsjaelland.dk

Overall Officials

Name	Affiliation	Role
Anne M Brinck, Msc Medicine	Zealand University Hospital, Roskilde, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zealand University Hospital	Recruiting	Roskilde		4000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided