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Completed

NCT Number: NCT04752852

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

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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Key information

Conditions

Thyroid Diseases Calcium Metabolism Disorders Endocrine System Diseases Hypocalcemia Laryngeal Diseases Metabolic Diseases Nutritional and Metabolic Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Tract Diseases Vocal Cord Dysfunction Water-Electrolyte Imbalance

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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

Placebo

Drug

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

Other names: normal saline (0.9%)

Primary outcomes

  1. Hypocalcaemia

    Time frame: 3 days

    Hypocalcaemia was defined as a corrected serum calcium level of less than 2 mmol/L.

  2. 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.

Sponsors and collaborators

Lead sponsor

Holy Family Hospital, Pakistan

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Feb 12, 2021
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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