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

University of Malaya

Status and phase: Unknown; Phase 4

Conditions: Hypocalcemia

Treatments: Drug: Calcium Gluconate; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04491357

2020225-8316

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Intervention arm

Experimental group

Description:

Intervention arm will receive 1 ampoule of intravenous calcium gluconate within 4 hours of skin closure post total thyroidectomy

Treatment:

Drug: Calcium Gluconate

Placebo arm

Placebo Comparator group

Description:

Placebo arm will receive 100ml of normal saline within 4 hours of skin closure post total thyroidectomy

Treatment:

Drug: Normal saline