The Effect of Anesthesia on Perioperative Muscle Weakness and Neuro-endocrine Stress Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in post-operative peripheral limb muscle weakness
研究概览
简要总结
The effect of surgery, in contrary to critical illness, on muscle weakness hasn't been thoroughly investigated. Recent data suggest that elective surgery may also induce muscle weakness. The neuro-endocrine stress response could be involved in the pathophysiology. Whether the mode of anesthesia/analgesia can influence muscle weakness, by influencing the neuro-endocrine stress response is unknown. Gaining insight in this matter could affect quality of care and benefit patient recovery and satisfaction.
详细描述
In this study, the investigators want to demonstrate whether the application of neuraxial anesthesia for elective surgery diminishes perioperative muscle weakness. Since spinal and epidural anesthesia/analgesia have been shown to influence the neuro-endocrine stress response, the possible underlying mediator of perioperative muscle weakness, the investigators will perform two different, but complementary, studies. In one study, patients scheduled for elective total hip arthroplasty will receive spinal anesthesia, without losing consciousness and maintaining a free airway, as compared to receiving general anesthesia. In another study, patients scheduled for a laparoscopic hemicolectomy will receive epidural anesthesia/analgesia during and after the surgery as compared to receiving no epidural anesthesia/analgesia. These studies allow the investigators to identify whether the application of neuraxial anesthesia/analgesia could diminish perioperative weakness and allow us to identify other possible mediators of perioperative muscle weakness, such as losing consciousness or receiving neuromuscular blockade.
This study has the potential to help to identify a new side-effect of elective surgery, namely perioperative muscle weakness, and to identify a possible treatment for this possible new complication, namely neuraxial anesthesia and analgesia, which might benefit many patients in the future. Furthermore, investigating the possible mediating role of the neuro-endocrine stress response might identify new therapeutic targets, such as glucagon modulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
盲法说明
Patients will be randomized using a computer-generated permuted block randomization sequence (variable block-size, 1:1 allocation). The randomization will be determined on the preoperative anesthesia assessment. After the randomisation, the investigator will inform the patient which anesthesia he/she will get during the operation
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
- •Aged 18 years or older.
- •Scheduled for elective total hip arthroplasty or hemicolectomy.
排除标准
- •Lack of informed consent or inability to give informed consent.
- •Urgent surgery, such as hip fracture.
- •Contra-indications for spinal or epidural analgesia, including but not limited to:
- •Infection at the site of puncture.
- •Coagulopathy.
- •Severe hypovolemia.
- •Severe aortic valve stenosis (cross sectional area < 1,3 cm2).
- •Severe mitralis valve stenosis (cross sectional area < 1,0 cm2).
- •Increased intracranial pressure.
- •Pre-existing neurological condition.
- •Severe spine deformity.
- •Body mass index (BMI) > 35 kg/m2
- •Hypersensitivity or known allergic reactions to any products used for anesthesia.
- •History of chronic opioid analgesics use.
- •Preoperative use of steroids:
- •Including, but not limited to: injection of hydrocortisone < 3 months before surgery.
- •Preexisting muscle disease
- •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
Hip surgery: spinal anesthesia
Patients scheduled to undergo elective total hip arthroplasty will receive spinal anesthesia in combination with monitored anesthesia care (MAC).
干预措施: Spinal anesthesia (Drug)
Hip surgery: general anesthesia
Patients scheduled to undergo elective total hip arthroplasty will receive general anesthesia
干预措施: General anesthesia (Drug)
Colectomy: general anesthesia and epidural analgesia
Patients scheduled to undergo elective laparoscopic hemicolectomy will receive general anesthesia combined with epidural analgesia (EA).
干预措施: General anesthesia and epidural analgesia (Drug)
Colectomy: general anesthesia
Patients will receive general anesthesia.
干预措施: General anesthesia (Drug)
结局指标
主要结局
Change in post-operative peripheral limb muscle weakness
时间窗: Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28)
The strength will be measured in the dominant hand using a Camry handgrip Dynamometer. The measurement will take place on the first day postoperatively, at day 7 and day 28 and will be compared to the preoperative measurement during the preoperative assessment
次要结局
- Change in post-operative lung function: vital capacity(Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28))
- Change in the neuro-endocrine stress response: Cortisol(Pre-operative (Day 0), end of surgery and postoperatively (Day 1))
- Change in the neuro-endocrine stress response: ACTH(Pre-operative (Day 0), end of surgery and postoperatively (Day 1))
- Change in glycemia levels(Pre-operative (Day 0), end of surgery and postoperatively (Day 1))
- Change in general health status(Pre-operative (Day 0) and postoperatively (Day1, Day7 and Day28))
- Change in post-operative lung function:forced expiratory volume(Pre-operative (Day 0) and postoperatively (Day 1, Day 7 and Day 28))
- Change in the neuro-endocrine stress response: Noradrenaline(Pre-operative (Day 0), end of surgery and postoperatively (Day 1))
研究者
Dimitri Dylst
Principal Investigator
Ziekenhuis Oost-Limburg