Nausea and Pain Prophylaxis During Thyroid Surgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00569920

Enrollment

120

Registered

2007-12-10

Start date

2007-09-30

Completion date

2008-12-31

Last updated

2009-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parathyroid Diseases, Thyroid Diseases

Brief summary

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.

Interventions

DRUGdexamethasone

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).

DRUGnatriumchloride 0,9%

iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Pain (VAS) and use of opioids. Nausea.	30 days

Secondary

Measure	Time frame
Nausea	30 days

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026