Nausea and Pain Prophylaxis During Thyroid Surgery

Sykehuset Telemark

Status: Completed

Conditions: Thyroid Diseases; Parathyroid Diseases

Treatments: Drug: dexamethasone; Drug: natriumchloride 0,9%

Study type: Interventional

Funder types: Other

Identifiers

NCT00569920

s8197.04

S-04189

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: natriumchloride 0,9%

2

Active Comparator group

Description:

dexamethasone "low-dose"

Treatment:

Drug: dexamethasone

Drug: dexamethasone

3

Active Comparator group

Description:

Dexamethasone "high-dose"

Treatment:

Drug: dexamethasone

Drug: dexamethasone