Hypocalcemia
Conditions
Keywords
Hypocalcaemia, Total thyroidectomy, Calcium gluconate
Brief 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.
Detailed 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.
Interventions
Intravenous calcium gluconate within 4 hours of skin closure after total thyroidectomy
DRUGNormal saline
Normal saline within 4 hours of skin closure after total thyroidectomy
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of hypocalcaemia after total thyroidectomy | first 48 hours after total thyroidectomy | To determine whether prophylactic infusion of calcium gluconate reduces the rate of hypocalcaemia after total thyroidectomy compared to placebo treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | first 48 hours after total thyroidectomy | To determine whether prophylactic infusion of calcium gluconate reduces the length of hospital stay compared to placebo group |
Countries
Malaysia
Contacts
Primary ContactKah Seng Khoo
Outcome results
None listed