Prophylactic Infusion of Calcium Gluconate Reducing the Rate of Hypocalcaemia After Total Thyroidectomy
NCT ID: NCT04491357
Last Updated: 2020-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2020-06-01
2022-06-01
Brief Summary
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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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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Intervention arm
Intervention arm will receive 1 ampoule of intravenous calcium gluconate within 4 hours of skin closure post total thyroidectomy
Calcium Gluconate
Intravenous calcium gluconate within 4 hours of skin closure after total thyroidectomy
Placebo arm
Placebo arm will receive 100ml of normal saline within 4 hours of skin closure post total thyroidectomy
Normal saline
Normal saline within 4 hours of skin closure after total thyroidectomy
Interventions
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Calcium Gluconate
Intravenous calcium gluconate within 4 hours of skin closure after total thyroidectomy
Normal saline
Normal saline within 4 hours of skin closure after total thyroidectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for total thyroidectomy in UMMC
Exclusion Criteria
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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University of Malaya
OTHER
Responsible Party
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Khoo Kah Seng
Surgical Resident, Department of Surgery, Principal Investigator
Principal Investigators
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Kah Seng Khoo
Role: PRINCIPAL_INVESTIGATOR
University of Malaya
Locations
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University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Countries
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Central Contacts
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Facility Contacts
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Kah Seng Khoo
Role: primary
Department of Surgery University of Malaya
Role: backup
References
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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.
Other Identifiers
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2020225-8316
Identifier Type: -
Identifier Source: org_study_id