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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2020-07-31

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

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Detailed Description

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Conditions

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Thyroid Diseases Hypocalcemia Vocal Cord Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

8 mg/2 ml dexamethasone IV, 60 minutes before the induction of anaesthesia

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 ml normal saline (0.9%) IV, 60 minutes before the induction of anaesthesia

Interventions

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Dexamethasone

8 mg/2 ml dexamethasone IV, 60 minutes before the induction of anaesthesia

Intervention Type DRUG

Placebo

2 ml normal saline (0.9%) IV, 60 minutes before the induction of anaesthesia

Intervention Type DRUG

Other Intervention Names

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normal saline (0.9%)

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes