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
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of hypocalcaemia after total thyroidectomy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-80 years old
- •Scheduled for total thyroidectomy in UMMC
排除标准
- •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
研究组 & 干预措施
Intervention arm
Intervention arm will receive 1 ampoule of intravenous calcium gluconate within 4 hours of skin closure post total thyroidectomy
干预措施: Calcium Gluconate (Drug)
Placebo arm
Placebo arm will receive 100ml of normal saline within 4 hours of skin closure post total thyroidectomy
干预措施: Normal saline (Drug)
结局指标
主要结局
Rate of hypocalcaemia after total thyroidectomy
时间窗: 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
次要结局
- Length of hospital stay(first 48 hours after total thyroidectomy)
研究者
Khoo Kah Seng
Surgical Resident, Department of Surgery, Principal Investigator
University of Malaya