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

Phase 4

• Conditions: Hypocalcemia
• Interventions: Drug: Normal saline; Drug: Calcium Gluconate

• Registration Number: NCT04491357
• Lead Sponsor: University of Malaya

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.

Study Timeline

• Study Start: 2020-06-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-29
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-31
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	Normal saline	Placebo arm will receive 100ml of normal saline within 4 hours of skin closure post total thyroidectomy
Intervention arm	Calcium Gluconate	Intervention arm will receive 1 ampoule of intravenous calcium gluconate within 4 hours of skin closure post total thyroidectomy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia