Randomized Controlled Trial on Efficacy of Preemptive 8 mg of Dexamethasone for Reducing Pain and Postoperative Nausea and Vomit After Thyroidectomy for Benign Disease.
Overview
- Phase
- Phase 2
- Intervention
- Dexamethasone
- Conditions
- Postoperative Pain
- Sponsor
- Ospedale Misericordia e Dolce
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Postoperative nausea and vomit (PONV) measured in 4 grades
- Last Updated
- 13 years ago
Overview
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.
Investigators
Marco Scatizzi
Md
Ospedale Misericordia e Dolce
Eligibility Criteria
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
Arms & Interventions
A (dexamethasone)
20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered
Intervention: Dexamethasone
A (dexamethasone)
20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered
Intervention: Thyroidectomy, total or partial
B (Control)
20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous
Intervention: saline solution
B (Control)
20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous
Intervention: Thyroidectomy, total or partial
Outcomes
Primary Outcomes
Postoperative nausea and vomit (PONV) measured in 4 grades
Time Frame: 8, 24, 32 and 48 hours after surgery
Secondary Outcomes
- 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)