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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-05

Study Completion Date

2020-11-30

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.

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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.

Conditions

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Hyperglycemia Steroid-induced Hyperglycemia Stress Surgery--Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Insulin treatment using standard measurements.

Group Type EXPERIMENTAL

Prevention of hyperglycemia

Intervention Type OTHER

Bigger focus on postoperative blood-glucose levels in order to reduce incidents of hyperglycemia and other surgical complications.

Control

Standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prevention of hyperglycemia

Bigger focus on postoperative blood-glucose levels in order to reduce incidents of hyperglycemia and other surgical complications.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No