Use of Prophylactic Steroids in the Prevention of Post-thyroidectomy Hypocalcaemia and Voice Dysfunction

Study Overview
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Brief Summary
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Total thyroidectomy for benign surgical pathologies is associated with risks related to temporary hypocalcaemia and vocal quality dysfunction. Dexamethasone, as an anti-inflammatory steroid, has been proposed to have a physiological effect on hypocalcaemia and voice quality. Investigators conducted a double-blinded controlled trial to assess the effect of preoperative dexamethasone on the vocal dysfunction and hypocalcaemia following thyroidectomy

Official Title
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Randomised Control Trial on the Use of Prophylactic Steroids in the Prevention of Post-thyroidectomy Hypocalcaemia and Voice Dysfunction

Conditions
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Thyroid Diseases, Hypocalcemia, Vocal Cord Dysfunction

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Benign thyroid condition. Patients without any preoperative corrected hypocalcaemia and voice or vocal quality dysfunction. Exclusion Criteria: Previous thyroid or neck surgery Known vocal cord dysfunction on laryngoscopy Hearing or voice problems History of gastroesophageal reflux and stomach ulcer disease Contraindications of steroids

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>Patients with odd numbers were assigned to group A. 8 mg/2 ml dexamethasone was injected intravenously sixty minutes before the induction of anaesthesia | Drug: Dexamethasone<br>* 8 mg/2 ml dexamethasone IV, 60 minutes before the induction of anaesthesia<br>|
| Placebo Comparator: Placebo<br>Patients with even numbers were assigned to group B. Two millilitres (ml) normal saline (0.9%) was given intravenously 60 minutes before the induction of anaesthesia. | Drug: Placebo<br>* 2 ml normal saline (0.9%) IV, 60 minutes before the induction of anaesthesia<br>* Other names: normal saline (0.9%);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypocalcaemia | Hypocalcaemia was defined as a corrected serum calcium level of less than 2 mmol/L. | 3 days | 
| Voice dysfunction | Signs and symptoms of voice dysfunction at 24 hours after thyroidectomy. Voice dysfunction was defined on voice analogue score from 0-100. Participants with Voice Analogue Score of less than 50 were labelled as having voice dysfunction, and participants with score more than 50 were considered as normal. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroidectomy, Postoperative Vocal cord dysfunction, Dexamethasone, Postoperative Hypocalcaemia