Nausea and Pain Prophylaxis During Thyroid Surgery

Study Overview
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Brief Summary
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Postoperative pain and nausea may diminish a patient's wellbeing, and may also delay rehabilitation, as well as increase the total cost of care and treatment. Opioids are effective drugs for treatment of pain, but with the disadvantage of side effects such as somnolence and nausea. The benefits of various types of non-opioid analgesic in reducing patients' postoperative need for opioids have been well-documented. One non-opioid prophylaxis documented for various surgery is short-term treatment with corticosteroids. The optimal dose of corticosteroids for peroperative nausea and pain prophylaxis is not well-documented. In our study we will attempt to determine whether the aforementioned benefits of corticosteroids are valid for a group of patients undergoing thyroid surgery. Hypothesis: Single-dose treatment with dexamethasone provides a better analgesic effect and/or reduced use of opioids than placebo in patients undergoing elective throid surgery. Higher dose of dexamethasone provide better and/or longer-lasting analgesic effects without influencing the side effect profile.

Official Title
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Nausea and Pain Prophylaxis During Thyroid Surgery, a Comparison of Low-Dose and High-Dose Dexamethasone to Placebo

Conditions
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Thyroid Diseases, Parathyroid Diseases

Intervention / Treatment
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* Drug: dexamethasone
* Drug: natriumchloride 0,9%
* Drug: dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatients scheduled for elective thyroid surgery and parathyroid surgery under general anesthesia. Informed consent Exclusion Criteria: Patients who use steroids Patients who use antiemetics Patients who use opioid analgesics Body weight > 100 kg BMI > 35

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: natriumchloride 0,9%<br>* iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.<br>|
| Active Comparator: 2<br>dexamethasone low-dose | Drug: dexamethasone<br>* IV dexamethasone 0,15 mg/kg bodyweight. Single-dose bolus injection after start of anesthesia. Medication is opened and administrated to the patient from a coded ampoule by the physician. The medication is diluted in such a way that 1 mL is equivalent to 10 kg body weight (1,5 mg/mL).<br>* Other names: Fortecortin;|
| Active Comparator: 3<br>Dexamethasone high-dose | Drug: dexamethasone<br>* IV dexamethasone 0,30 mg/kg body weight. Drug diluted to 3,0 mg/mL and administrated in same way as arm 2.<br>* Other names: fortecortin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (VAS) and use of opioids. Nausea. |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea |  | 30 days |