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

Ospedale Misericordia e Dolce

Status and phase: Unknown; Phase 2

Conditions: Postoperative Pain; Postoperative Vocal Function; Postoperative Nausea and Vomit; Thyroidectomy

Treatments: Drug: Dexamethasone; Procedure: Thyroidectomy, total or partial; Drug: saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT00888303

MD123

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

A (dexamethasone)

Active Comparator group

Description:

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

Treatment:

Procedure: Thyroidectomy, total or partial

Drug: Dexamethasone

B (Control)

Placebo Comparator group

Description:

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

Treatment:

Drug: saline solution

Procedure: Thyroidectomy, total or partial