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

Holy Family Hospital, Pakistan

Status: Completed

Conditions: Thyroid Diseases; Vocal Cord Dysfunction; Hypocalcemia

Treatments: Drug: Dexamethasone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04752852

233/HFH12/14

Details and patient eligibility

About

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

Enrollment: 192 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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192 participants in 2 patient groups, including a placebo group

Dexamethasone

Experimental group

Description:

Patients with odd numbers were assigned to group A. 8 mg/2 ml dexamethasone was injected intravenously sixty minutes before the induction of anaesthesia

Treatment:

Drug: Dexamethasone

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo