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Status unknownNCT00888303Updated Sep 5, 2012

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

A Phase 2 interventional study of Dexamethasone and saline solution in Postoperative Pain, Postoperative Nausea and Vomit and Postoperative Vocal Function, sponsored by Ospedale Misericordia e Dolce. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-05.

Sponsored by Ospedale Misericordia e Dolce · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Postoperative Pain
  • Postoperative Nausea and Vomit
  • Postoperative Vocal Function
  • Thyroidectomy
03

In context

Nausea

822 studies on the registry are indexed under Nausea; 104 are open to participants now.

This study's planned enrollment of 80 is below the median of 115 across 703 interventional studies indexed under Nausea.

Browse Nausea studies →

Lead sponsor

Ospedale Misericordia e Dolce is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age > 18 years
  • Patients undergoing thyroidectomy

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    A (dexamethasone)

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

    Drug: Dexamethasone · Procedure: Thyroidectomy, total or partial

  • Placebo comparator
    B (Control)

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

    Drug: saline solution · Procedure: Thyroidectomy, total or partial

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

06

What researchers measure

Primary outcomes

  1. Postoperative nausea and vomit (PONV) measured in 4 grades

    Time frame: 8, 24, 32 and 48 hours after surgery

Secondary outcomes

  1. Postoperative pain after thyroidectomy measured in a 0-100 Visual analog scale

    Time frame: 8, 24, 32 and 48 hours after surgery

  2. Vocal function measured in a 0-100 Visual analog scale

    Time frame: 8, 24, 32 and 48 hours after surgery

07

Study locations

1 of 1 sites recruiting
  • Misericordia and Dolce Hodpital
    Prato, Po 59100, Italy
    • Francesco Feroci, MD · Contact · fferoci@yahoo.it · +393389592375
    • Francesco Feroci, MD · Principal investigator
    • Andrea Borrelli, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • Worni M, Schudel HH, Seifert E, Inglin R, Hagemann M, Vorburger SA, Candinas D. Randomized controlled trial on single dose steroid before thyroidectomy for benign disease to improve postoperative nausea, pain, and vocal function. Ann Surg. 2008 Dec;248(6):1060-6. doi: 10.1097/SLA.0b013e31818c709a. PubMed 19092351 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00888303
Lead sponsor
Ospedale Misericordia e Dolce
Responsible party
Marco Scatizzi (Md, Ospedale Misericordia e Dolce) — Principal investigator
First posted
Apr 27, 2009
Start date
Jan 2009
Primary completion
Oct 2012 (estimated)
Completion
Oct 2012 (estimated)
Last update
Sep 5, 2012

Study contacts

Francesco Feroci, MD
Contact
fferoci@yahoo.it
+393398382381
Marco Scatizzi, MD
Contact
marco.scatizzi@usl4.toscana.it
+39574434647
Marco Scatizzi, MD
study chair · Misericordia and Dolce Hospital
Marco Rettori, MD
study director · Misericordia and Dolce Hospital
Francesco Feroci, MD
principal investigator · Misericordia and Dolce Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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