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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of Prophylactic Infusion of Calcium Gluconate Compared to Placebo in Reducing the Rate of Hypocalcaemia After Total Thyroidectomy: A Double-Blinded, Randomized Controlled Trial

Conditions
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Hypocalcemia

Intervention / Treatment
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* Drug: Calcium Gluconate
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Intervention arm will receive 1 ampoule of intravenous calcium gluconate within 4 hours of skin closure post total thyroidectomy | Drug: Calcium Gluconate<br>* Intravenous calcium gluconate within 4 hours of skin closure after total thyroidectomy<br>* Other names: Intravenous calcium gluconate;|
| Placebo Comparator: Placebo arm<br>Placebo arm will receive 100ml of normal saline within 4 hours of skin closure post total thyroidectomy | Drug: Normal saline<br>* Normal saline within 4 hours of skin closure after total thyroidectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hypocalcaemia after total thyroidectomy | To determine whether prophylactic infusion of calcium gluconate reduces the rate of hypocalcaemia after total thyroidectomy compared to placebo treatment | first 48 hours after total thyroidectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | To determine whether prophylactic infusion of calcium gluconate reduces the length of hospital stay compared to placebo group | first 48 hours after total thyroidectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total thyroidectomy, Hypocalcaemia, Calcium gluconate