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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Optimization in the Postoperative Treatment in Head and Neck--surgical Patients -- Improvement in Glycemic Control to Reduce the Incidence of Hyperglycaemia and Associated Complications.

Conditions
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Hyperglycemia Steroid-induced, Hyperglycemia Stress, Surgery--Complications

Intervention / Treatment
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* Other: Prevention of hyperglycemia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prevention of hyperglycemia. The study will involve an intervention and a control group - only the intervention group will receive different treatment and the other standard care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Insulin treatment using standard measurements. | Other: Prevention of hyperglycemia<br>* Bigger focus on postoperative blood-glucose levels in order to reduce incidents of hyperglycemia and other surgical complications.<br>|
| No Intervention: Control<br>Standard care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic load (mmol) | All blood glucose levels of the participants will be measured every 30. min - all values will be used to make an area under the curve in final statistics. | 1-5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature (degree celcius) | The temperature will be measured 3 times a day for each participant | 1-5 days | 
| C-Peptide | Blood sample - Will be measured 3 times | 1-5 days | 
| Strength of Hand grip (kg) | Will be measured 3 times. Maximal values of 3 attempts | 20 days | 
| Number of re-Hospitalizations | counted | 30 days postoperatively | 
| Number of re-Hospitalizations | counted | Up to 3 months after the first discharge | 
| Intracellular hydration (liters) | Will be measured by bioimpedance and blood sample of hematocrit | 20 days | 
| C-reactive protein (CRP) concentration | Blood sample - will be measured 3 times | 20 days | 
| Blood glucose (mmol/l) | Will be measured by electronical device called Freestyle Libre (CGM) | 1-5 days - every 30. min. | 
| Functional recovery | Performa status and FOIS (Functional Oral Intake Scale = degree of swallowing problems/dysphagia) scale will be used (points 1-7) | 20 days |