Randomised Control Trial on the Use of Prophylactic Steroids in the Prevention of Post-thyroidectomy Hypocalcaemia and Voice Dysfunction
Overview
- Phase
- Not Applicable
- Intervention
- Dexamethasone
- Conditions
- Thyroid Diseases
- Sponsor
- Holy Family Hospital, Pakistan
- Enrollment
- 192
- Primary Endpoint
- Hypocalcaemia
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
Investigators
Raheel Ahmad
Principal Investigator
Holy Family Hospital, Pakistan
Eligibility Criteria
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
Arms & Interventions
Dexamethasone
Patients with odd numbers were assigned to group A. 8 mg/2 ml dexamethasone was injected intravenously sixty minutes before the induction of anaesthesia
Intervention: Dexamethasone
Placebo
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Hypocalcaemia
Time Frame: 3 days
Hypocalcaemia was defined as a corrected serum calcium level of less than 2 mmol/L.
Voice dysfunction
Time Frame: 24 hours
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.