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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04752852
Enrollment
192
Registered
2021-02-12
Start date
2014-01-31
Completion date
2020-07-31
Last updated
2021-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypocalcemia, Thyroid Diseases, Vocal Cord Dysfunction

Keywords

Thyroidectomy, Postoperative Hypocalcaemia, Postoperative Vocal cord dysfunction, Dexamethasone

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

Interventions

DRUGDexamethasone

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

DRUGPlacebo

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

Sponsors

Holy Family Hospital, Pakistan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Hypocalcaemia3 daysHypocalcaemia was defined as a corrected serum calcium level of less than 2 mmol/L.
Voice dysfunction24 hoursSigns 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026