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An Optimization in the Postoperative Treatment in Head and Neck--surgical Patients.

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University of Copenhagen

Status

Unknown

Conditions

Hyperglycemia Stress
Surgery--Complications
Hyperglycemia Steroid-induced

Treatments

Other: Prevention of hyperglycemia

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Based on glycemic load (overall increase in blood glucose), it is investigated whether better glycemic control (large fluctuations in blood glucose to abnormal values are attempted) can improve the postoperative phase of head and neck surgical patients who receive Dexamethasone (glucocorticoid). Furthermore it is examined whether this optimization in treatment can result in reduced hospitalization time and fewer re-admissions.

Hypothesis:

Continuous blood glucose measurement and insulin therapy will optimize the postoperative phase of the embedded head and neck patient receiving Dexamethasone by reducing the incidence of hyperglycaemia and associated complications.

Full description

After surgical intervention, an insulin resistance condition will occur because of the following stress response. This condition will for the majority of cases results in poor glycemic control - and there will be a risk of hyperglycaemia in the hospitalized patient. This condition affects all cells in the body and therefore has associated complications such as bigger risk at multiple infections, longer healingprocess, poorer fluid balance, etc. Hyperglycaemia is associated with a poorer outcome for the patient, which can cause an increase in hospitalization days and multiple re-admissions. It is also common for the postoperative patient to experience nausea and pain as a result of both surgery and anesthesia and immobilization. To counter this, the patient receives Dexamethasone (steroid treatment).

This experiment is based on the fact that there is still insufficient attention at this postoperative insulin resistance. In a large randomized study from 2001(Van den Berghe), insulin therapy was initiated for intensive patients. This study points out that even moderate increases in blood glucose are associated with increased morbidity and that insulin therapy is both capable of reducing mortality and morbidity.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All embedded head and neck-surgical patients receiving large packs of pre-medication, including 8-16 mg glucocorticoid.
  • >18 yrs.
  • Expected admission time of a minimum of 1 day

Exclusion criteria

  • Patients who do not understand and / or speak Danish
  • Patients who are demented
  • Patients included in primary robot surgery
  • Ear-surgical patients
  • Sinus surgery patients
  • Day surgery patients
  • Plastic surgical patients
  • Patients who are scheduled to transfer to ICU
  • Patients with Diabetes Mellitus type I
  • Patients on dialysis
  • If all preoperative blood samples and tests are not completed
  • Type 2 diabetics in insulin therapy
  • Anesthesia patients
  • Patients who have received large packages of pre-medication twice - eg. due to cancelled operation.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Intervention
Experimental group
Description:
Insulin treatment using standard measurements.
Treatment:
Other: Prevention of hyperglycemia
Control
No Intervention group
Description:
Standard care.

Trial contacts and locations

1

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Central trial contact

Sara K. Nielsen, Stud.Cand; Josefine Q. Olsen, Stud.Cand

Data sourced from clinicaltrials.gov

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