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

Thyroid Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752852
• Other study ID #: 233/HFH12/14
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: July 2020

Study information

• Verified date: February 2021
• Source: Holy Family Hospital, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: July 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypocalcemia
• Thyroid Diseases
• Vocal Cord Dysfunction

Intervention

Drug:
• Dexamethasone
8 mg/2 ml dexamethasone IV, 60 minutes before the induction of anaesthesia
• Placebo
2 ml normal saline (0.9%) IV, 60 minutes before the induction of anaesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Holy Family Hospital, Pakistan

References & Publications (2)

Kolahdouzan M, Iraj B, Eslamian M, Harandizadeh M, Meamar R. Preventive Effect of Dexamethasone Therapy on the Transient Hypoparathyroidism through Total Thyroidectomy. Iran J Otorhinolaryngol. 2019 Mar;31(103):73-80. — View Citation

Worni M, Schudel HH, Seifert E, Inglin R, Hagemann M, Vorburger SA, Candinas D. Randomized controlled trial on single dose steroid before thyroidectomy for benign disease to improve postoperative nausea, pain, and vocal function. Ann Surg. 2008 Dec;248(6):1060-6. doi: 10.1097/SLA.0b013e31818c709a. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypocalcaemia	Hypocalcaemia was defined as a corrected serum calcium level of less than 2 mmol/L.	3 days
Primary	Voice dysfunction	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.	24 hours