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

Not Applicable

Completed

• Conditions: Hypocalcemia; Vocal Cord Dysfunction; Thyroid Diseases
• Interventions: Drug: Placebo; Drug: Dexamethasone

• Registration Number: NCT04752852
• Lead Sponsor: Holy Family Hospital, Pakistan

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2019-12
• Study Completion: 2020-07
• Status Verified: 2021-02
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-11
• Last Update Submitted: 2021-02-11
• Study First Posted: 2021-02-12
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• Benign thyroid condition.
• Patients without any preoperative corrected hypocalcaemia and voice or vocal quality dysfunction.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Dexamethasone	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

Primary Outcome Measures

Name	Time	Method
Hypocalcaemia	3 days	Hypocalcaemia was defined as a corrected serum calcium level of less than 2 mmol/L.
Voice dysfunction	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.