Single Dose Steroid Before Thyroidectomy for Benign Disease to Improve Postoperative Nausea, Pain, and Vocal Function

Randomized Controlled Trial on Efficacy of Preemptive 8 mg of Dexamethasone for Reducing Pain and Postoperative Nausea and Vomit After Thyroidectomy for Benign Disease.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00888303

Enrollment

Registered

2009-04-27

Start date

2009-01-31

Completion date

2012-10-31

Last updated

2012-09-05

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

Conditions

Postoperative Nausea and Vomit, Postoperative Pain, Postoperative Vocal Function, Thyroidectomy

Brief summary

The purpose of this study is to evaluate the efficacy of 8 mg of dexamethasone administered prior surgery, to reduce pain, postoperative nausea and vomiting and to improve vocal function after thyroidectomy for benign disease.

Interventions

DRUGDexamethasone

20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered

DRUGsaline solution

20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous

PROCEDUREThyroidectomy, total or partial

Surgical standard intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \> 18 years * Patients undergoing thyroidectomy

Exclusion criteria

* Patients who had received antiemetic therapy within 48 hours before surgery * Patients with depression * Chronic pain disorder * Insulin-dependent diabetes mellitus * History of severe and/or repeated PONV after previous minor surgery, that led to change from standard anesthetic protocol * Pregnancy * Age \< 18 years * Patients who had known malignant disease or had undergone previous thyroid or neck surgery

Design outcomes

Primary

Measure	Time frame
Postoperative nausea and vomit (PONV) measured in 4 grades	8, 24, 32 and 48 hours after surgery

Secondary

Measure	Time frame
Postoperative pain after thyroidectomy measured in a 0-100 Visual analog scale	8, 24, 32 and 48 hours after surgery
Vocal function measured in a 0-100 Visual analog scale	8, 24, 32 and 48 hours after surgery

Countries

Italy

Contacts

Primary ContactFrancesco Feroci, MD

fferoci@yahoo.it+393398382381

Backup ContactMarco Scatizzi, MD

marco.scatizzi@usl4.toscana.it+39574434647

Outcome results

None listed

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