Prophylactic Infusion of Calcium Gluconate Reducing the Rate of Hypocalcaemia After Total Thyroidectomy

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    University of Malaya
Updated on 19 February 2024

Summary

Post-total thyroidectomy hypocalcaemia is a common complication with the rate ranging from 13-49% in a meta-analysis. However, the rate in UMMC in 2018 and 2019 were 40% and 23% respectively. It lead to prolonged hospital stay and patient dissatisfaction in the event of hypocalcaemia.

Research question: Does prophylactic intravenous calcium infusion reduces the rate of post-total thyroidectomy hypocalcaemia? This study will conduct in UMMC endocrine surgery unit with the target population who scheduled for total thyroidectomy in UMMC between 1/6/2020-1/6/2022.

After obtaining consent from participants, they will be randomised into intervention and placebo group with the ratio of 1:1. Intervention group will receive the intravenous calcium gluconate infusion and placebo group will receive saline infusion within 4 hour of skin closure. Both groups will have their serum calcium measure at 6,12,24,36,48-hour mark post surgery. Both groups will receive same oral calcium supplements.

Description

All participating patients will be randomised into intervention and placebo arm with 1:1 ratio. Intervention group will receive 1 ampoule of intravenous calcium gluconate within 4 hours of post total thyroidectomy, whereas the placebo group will received 100ml of normal saline only. Both groups will receive same oral calcium supplements post surgery. Both groups will have their serum calcium measure at 6,12,24,36,48-hour mark post surgery.

Details
Condition Hypocalcemia
Age 18-80 years
Treatment Normal saline, Calcium Gluconate
Clinical Study IdentifierNCT04491357
SponsorUniversity of Malaya
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Age between 18-80 years old
Scheduled for total thyroidectomy in UMMC

Exclusion Criteria

Their age outside the range of 18-80
Have parathyroid disorders or end stage renal failure
On calcium or vitamin D supplements prior to surgery
Have deranged calcium homeostasis (outside the normal range of 2.2-2.6 mmol/L)
Scheduled for total thyroidectomy plus lymph node dissection
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