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.
Studieoversigt
Status
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Anne M Brinck, MSc Medicine
- Telefonnummer: +4552119003
- E-mail: abrinc@regionsjaelland.dk
Studiesteder
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Roskilde, Danmark, 4000
- Rekruttering
- Zealand University Hospital
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Kontakt:
- Anne M Brinck, MSc Medicine
- Telefonnummer: +4552119003
- E-mail: abrinc@regionsjaelland.dk
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Characterization of hyperglycemia I
Tidsramme: Up to 10 days postoperatively
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Peak glucose level
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Up to 10 days postoperatively
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Characterization of hyperglycemia II
Tidsramme: Up to 10 days postoperatively
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Duration of hyperglycemia
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Up to 10 days postoperatively
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Correlation between pre- and postoperative glucose trajectories
Tidsramme: Up to 10 days postoperatively
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How does baseline dysglyceamia (elevated FPG or HbA1C) correlates to intra- and postoperative hyperglycemia
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Up to 10 days postoperatively
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Subgroup analyses
Tidsramme: Up to 10 days postoperatively
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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
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Up to 10 days postoperatively
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Anne M Brinck, Msc Medicine, Zealand University Hospital, Roskilde, Denmark
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- SJ-1121
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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