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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Intervention arm will receive 1 ampoule of intravenous calcium gluconate within 4 hours of skin closure post total thyroidectomy |
|
| Placebo arm | Placebo Comparator | Placebo arm will receive 100ml of normal saline within 4 hours of skin closure post total thyroidectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Gluconate | Drug | Intravenous calcium gluconate within 4 hours of skin closure after total thyroidectomy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kah Seng Khoo | Contact | +60172489272 | kahseng901209@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kah Seng Khoo | University of Malaya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Malaya Medical Centre | Recruiting | Kuala Lumpur | 59100 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39282041 | Derived | Khoo KS, Yeo A, Mirzan Asfian MRB, Ng KL. The use of prophylactic infusion of calcium gluconate compared to placebo in reducing the rate of early hypocalcaemia after total thyroidectomy: a double-blinded, randomized controlled trial. Gland Surg. 2024 Aug 31;13(8):1378-1386. doi: 10.21037/gs-24-190. Epub 2024 Aug 28. |
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Not to share IPD to other researchers
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| ID | Term |
|---|---|
| D006996 | Hypocalcemia |
| ID | Term |
|---|---|
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |
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| ID | Term |
|---|---|
| D002125 | Calcium Gluconate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D005942 | Gluconates |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Normal saline | Drug | Normal saline within 4 hours of skin closure after total thyroidectomy |
|
| D009930 |
| Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |