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Recruiting NCT07573930

Metabolic Control in Anesthesia and Surgery

Observational Anesthesia Continuous Glucose Monitoring Hyperglycemia Steroid-induced Hyperglycemia Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Anesthesia, Continuous Glucose Monitoring, Hyperglycemia Steroid-induced, Hyperglycemia Stress. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Characterization of hyperglycemia I [Time frame: Up to 10 days postoperatively]
  • Characterization of hyperglycemia II [Time frame: Up to 10 days postoperatively]
Secondary outcome measures (2)
  • Correlation between pre- and postoperative glucose trajectories [Time frame: Up to 10 days postoperatively]
  • Subgroup analyses [Time frame: Up to 10 days postoperatively]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Zealand University Hospital — Roskilde

Identifiers

NCT: NCT07573930 · SJ-1121

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗