Effect of High vs Low Dose Intravenous Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy- a Randomized, Double-blind, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Transfer to Post-anesthesia Care Unit (PACU)
研究概览
简要总结
The aim of this study is to investigate the effect of a single preoperative high-dose steroid injection on complications in the immediate postoperative phase after breast cancer surgery, with removal of the breast (mastectomy). Primary outcome is the proportion patients who require transfer to the post anaesthesia care unit (PACU) and the proportion that can be transferred directly to the ward. Secondary outcomes are organospecific complications in the postanesthesia phase, pain and nausea the first 5 days, seroma and wound infection the first 14 days and readmissions the first 30 days after surgery.
The investigators hypothesize that the frequency of transfer to the PACU and organospecific complications will be lower among patients receiving high dose dexamethasone. The investigators hypothesize, that there will be no difference in wound infections, seroma or readmissions.
详细描述
Post-surgery, patients are traditionally observed and treated in post-anesthesia care units (PACU) until they are discharged to the ward (or directly home) assessed by standardized international discharge criteria.
The research project "Why in PACU?" (Rigshospitalet, Denmark), has since the beginning of 2016 systematically collected and analyzed procedure-related complications in the recovery phase. The complications include pain, nausea/vomiting, circulatory and respiratory problems, orthostatic intolerance and cognitive disorders. Common to all the above-mentioned post-operative problems are the possible links to the inflammatory response caused by the surgical trauma.
Glucocorticoids can in this context be central for the reduction of acute postoperative organ dysfunctions, caused by the anti-inflammatory effect. In a number of different surgical procedures, single dose, pre-operative glucocorticoids have been shown to reduce post-operative nausea and vomiting (PONV), acute pain and need of opioids as well as accelerate the convalescence.
Meta-analyses also showed that single-dose administration of glucocorticoids (methylprednisolone and dexamethasone) for surgical patients is safe as opposed to long-term treatment.
Based on positive results in other procedure-specific studies, all mastectomy patients at Rigshospitalet, have received pre-operative high-dose steroids, in the form of 24 mg dexamethasone injection since mid-2015. This has resulted in a decrease in the proportion of patients who need observation in PACU from 30 % to 10 %. The reduction is primarily due to less pain, less sedation, and lower opioid administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •planned unilateral mastectomy with or without axillary dissection or sentinel node in the study period
- •informed signed consent
排除标准
- •Chronic/ongoing use of glucocorticoids (except inhalation therapy)
- •ongoing use of immunosuppressive therapy
- •insulin dependent diabetes
- •pregnancy/breastfeeding
- •allergies toward study medication, or medication in a standard treatment
- •contralateral surgery (lumpectomy/mastectomy) at time of mastectomy
- •surgery cannot be performed
研究组 & 干预措施
Dexamethasone 8 mg
Dexamethasone 8 mg pre-operative
干预措施: Dexamethasone (Drug)
Dexamethasone 24 mg
Dexamethasone 24 mg pre-operative
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Transfer to Post-anesthesia Care Unit (PACU)
时间窗: Within 1 hour post-surgery
Number of patients meeting criteria for transfer to PACU post-surgery
次要结局
- Discharge Score, Arrival at Ward(within 3 hours)
- Post Operative Nausea and Vomiting (PONV).(days 0-4)
- Quality of Sleep(days 0-4)
- Discharge Score, Arrival at PACU(within 3 hours)
- Total Length of Stay in PACU(12 hours)
- Discharge Score,(Modified Aldrete Discharge Score), Operating Room(At transfer from operating room, within 1 hour post-surgery)
- Total Length of Stay in Hospital(24-48 hours)
- Secondary Transfer(24-48 hours)
- Number of Participants With Complication(24 hours)
- Pain, Numeric Rating Scale(days 0-4)
- Number of Participants With Seroma, Requiring Treatment(14 days)
- Readmission(30 days)
- Mental Status(days 0-4)
研究者
Kristin Julia Steinthorsdottir
Principal investigator, MD, Clinical assistant
Rigshospitalet, Denmark