CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients
概览
- 阶段
- 4 期
- 干预措施
- NaCl 0.9%
- 疾病 / 适应症
- 未指定
- 发起方
- Ziekenhuis Oost-Limburg
- 入组人数
- 751
- 试验地点
- 1
- 主要终点
- Post operative muscle weakness
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
Major surgery induces a systemic inflammatory response, which can influence the post-operative morbidity, such as coagulation disorders and post-operative muscle weakness, hampering early recovery after surgery.
Single administration of high dose corticosteroids is known to reduce this inflammatory response and could possibly improve the post-operative outcome.
The CORTERAS study will evaluate the effect of administration of corticosteroids, as compared to no corticosteroids, on postoperative muscle weakness and quality of recovery after surgery in elderly patients.
详细描述
The number of elderly patients undergoing surgery is expected to increase in the coming years, due to the increase in life expectancy in the developing world. Compared to younger surgical patients, the older patients are at greater risk of mortality and morbidity after surgery. Post-operative fatigue is an important complication after surgery. Not only is it reported by patients as one of the most distressing symptoms, it is also thought to be a significant contributor to delayed recovery after surgery. From a pathophysiological point of view, muscle weakness could be a major contributor to this post-operative fatigue. Recent studies showed a profound reduction in muscle strength after surgery in elderly patients, which lasted for more than 3 months after surgery. This decrease in muscle strength might be induced by an excessive inflammatory response to surgery. Glucocorticosteroids are capable of tampering an excessive inflammatory response to surgery and could improve the quality of recovery after surgery. However, a possible effect on post-operative muscle weakness hasn't been specifically investigated. Therefore, the main objective of this prospective clinical trial is to evaluate the effect of corticosteroids on early post-operative outcome, focusing on muscle weakness, in elderly patients (≥60 years) undergoing surgery.
研究者
Steven Thiessen
Principal Investigator
Ziekenhuis Oost-Limburg
入排标准
入选标准
- •Aged 60 years or older.
- •Scheduled for one of the predefined surgical procedures:
- •off-pump coronary bypass surgery
- •on-pump coronary bypass surgery
- •aortic and mitral valve replacement
- •laparoscopic hemicolectomies
- •thoracoscopic lung resections
- •femoral popliteal and tibial bypass surgery and femoral profundoplasty
- •laparoscopic radical prostatectomies
排除标准
- •Lack of informed consent or inability to give informed consent.
- •Severe postoperative nausea \& vomiting (PONV), needing corticosteroids as PONV prophylaxis.
- •Urgent, not elective surgery
- •Hypersensitivity or known allergic reactions to methylprednisolone
- •Preoperative systemic use of steroids:
- •Including, but not limited to, the use of corticosteroids \> 4 weeks before surgery of at least 4 mg methylprednisolone equivalents.
- •Excluding inhalational and topical steroids
- •Preexisting muscle disease o Including, but not limited to: Steinert's disease, amyotrophic lateral sclerosis (ALS), Duchenne dystrophy, amputation of dominant arm or hand.
研究组 & 干预措施
Placebo
100 ml of NaCl 0,9%, not containing corticosteroids, given at induction of anaesthesia, before surgery. If a patient will receive cardiopulmonary bypass (CPB) during his operation, a repeat dose of 100 ml of NaCl 0,9% will be administered at the beginning of CPB.
干预措施: NaCl 0.9%
Methylprednisolone
250 mg of methylprednisolone made up with 100 ml NaCl 0,9%, given at the induction of anaesthesia, before surgery. If a patient will receive cardiopulmonary bypass (CPB) during his operation, a repeat dose of 250 mg methylprednisolone will be administered at the beginning of CPB.
干预措施: Methylprednisolone
结局指标
主要结局
Post operative muscle weakness
时间窗: Pre-operative and Post operative day 1
decrease in muscle strength post-operatively, assessed by comparing the handgrip strength of the dominant hand, measured by the JAMAR dynamometer, on day 1 following surgery as compared to the preoperative value
次要结局
- Post operative muscle weakness(Pre-operative and Post operative day 1, 3 and 5)
- Maximum inspiratory pressure as measure of respiratory muscle function(Pre-operative and Post operative day 1, 3 and 5)
- Post operative fatigue(Pre-operative and Post operative day 1, 3, 5 and 28)
- Quality of recovery (QOR)(Post operative day 1, 3 and 5)
- Functioning at day 28(Pre-operative and Post operative day 28)
- Coagulation disorder(postoperatively first 24 hours)
- Sleeping pattern(10 consecutive nights, starting 3 days before surgery)
- Sleep quality(3 days before and 10 days after surgery)
- Sleep chronotype(3 days before surgery)
- Sleeping EEG pattern(first postoperative night)